Tag: PAD
Endologix announces 36-month results of DETOUR2 study
Endologix has announced the final 36-month results from the DETOUR2 study—a prospective, single-arm, international, multicentre clinical evaluation of the novel Detour system for fully...
Bolt Medical announces completion of RESTORE ATK and RESTORE BTK pivotal...
Bolt Medical has announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the company's Bolt intravascular lithotripsy...
New data add to body of research demonstrating safety and effectiveness...
Results from two studies evaluating the utility of atherectomy for peripheral endovascular interventions have just been released as late-breaking data presentations at VIVA 2024...
Two-year LIFE-BTK data show sustained benefits of drug-eluting resorbable scaffold for...
Presented today, late-breaking data from the second year of the LIFE-BTK clinical trial demonstrate the long-term effectiveness of the US Food and Drug Administration...
US FDA grants R3 Vascular IDE approval for ELITE-BTK pivotal trial...
R3 Vascular today announced that the US Food and Drug Administration (FDA) has granted the company investigational device exemption (IDE) approval to initiate its...
Innovation in vascular surgery: Balancing progress with patient safety
A debate at this year’s European Society for Vascular Surgery (ESVS) annual meeting (24–27 September, Kraków, Poland) centred on innovation in vascular surgery, with...
Vesalio announces clinical study initiative for recently launched pVasc thrombectomy system
Vesalio has announced the initiation of a prospective, single-arm, multicentre study supporting the recently launched pVasc thrombectomy system for non-surgically removing peripheral occlusions. This...
Novel RCT framework set to improve design and reporting of endovascular...
Pilot testing has shown that a new framework—dubbed Endo-STAR—can be used to describe and standardise endovascular interventions for peripheral arterial disease (PAD) within a...
AVS enrols first patient in US pivotal intravascular lithotripsy study
Amplitude Vascular Systems (AVS) recently announced that it has enrolled the first patient in its US pivotal trial for pulsatile intravascular lithotripsy (IVL) therapy....
Shockwave Medical expands US peripheral IVL portfolio with enhanced catheter
Shockwave Medical, part of Johnson & Johnson MedTech, has announced the full US launch of its Shockwave E8 peripheral intravascular lithotripsy (IVL) catheter, following...
Study: Social support associated with better PAD health outcomes
Patients with peripheral arterial disease (PAD) reporting lower levels of social support experience worse health outcomes, a new Yale-led study finds.
Social support is thought...
New ESC guidelines combine peripheral arterial and aortic diseases for first...
The European Society of Cardiology (ESC) has today published its 2024 guidelines for the management of peripheral arterial and aortic diseases (PAAD), evaluating these...
Humacyte’s ATEV granted US FDA Regenerative Medicine Advanced Therapy designation for...
Humacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational...
AVS receives IDE approval from US FDA for pivotal intravascular lithotripsy...
Amplitude Vascular Systems (AVS) announced today that it has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to...
Vascular News 102 – June 2024: North American Edition
In this issue:
Common ground: High-quality data and individualised care emerge as non-negotiables in CX 2024 aortic debates
Studies highlight need for tailored treatment...
Vascular News 102 – June 2024: European Edition
In this issue:
Common ground: High-quality data and individualised care emerge as non-negotiables in CX 2024 aortic debates
Studies highlight need for tailored treatment...
PAD guideline update from ACC, AHA and others centres multispecialty care
New multisociety clinical practice guidelines for the management of lower extremity peripheral arterial disease (PAD) have been published online in the Journal of the...
Ultrafast contrast-enhanced ultrasound for PAD patients shows promise in early feasibility...
Majorie van Helvert (University of Twente, Enschede, The Netherlands) and Michel Reijnen (Rijnstate Hospital, Arnhem, The Netherlands) are currently conducting research on ultrafast contrast-enhanced...
Studies highlight need for tailored treatment options for women with peripheral...
New clinical results highlight the need for inclusive approaches and comprehensive examinations of treatment options for peripheral arterial disease (PAD), including endovascular therapy and...
CX 2024: Paclitaxel device restrictions “did cause harm”
“Unfortunately, we are doing worse for our patients today,” were the sobering thoughts of Eric Secemsky (Boston, United States) during a late-breaking presentation in...
New data and heated debates set to spark controversy in CX...
“These will be important, salutary lessons. Should a controversy arise again involving a proven efficacious therapy, we now know that stopping access to that...
Vascular News’ top 10 most popular stories of March 2024
Transcarotid artery revascularisation (TCAR) features in three of March's most popular Vascular News stories, with a talk on the future of aortic repair and...
Rotarex™S: A 25-year legacy continues
This advertorial, sponsored by BD, is only available in selected countries and geographies.
This year marks a significant milestone as BD celebrates 25 years...
US FDA Breakthrough Device designation granted for DynamX BTK for use...
Elixir Medical has announced Breakthrough Device designation by the US Food and Drug Administration (FDA) for its novel DynamX BTK System, an implant for...
Bentley and Cook Medical enter US distribution agreement for BeBack crossing...
Cook Medical and Bentley today announced a distribution agreement for the BeBack crossing catheter in the USA, with Cook assuming commercial responsibilities for the Bentley...
Vascular News’ top 10 most popular stories of February 2024
February's top 10 includes an update from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on the use of paclitaxel-coated devices for peripheral...
BD announces first patient enrolled in PAD vascular covered stent trial
BD has announced the enrolment of the first patient in the AGILITY investigational device exemption (IDE) study, which will assess the safety and effectiveness...
Endologix initiates postmarket study of the Detour system
Endologix has announced the initiation of the Percutaneous transmural arterial bypass (PTAB)1 postmarket study. This study marks the beginning of a comprehensive postmarket study...
Cagent Vascular raises US$30 million series C financing
Cagent Vascular has announced a series C financing close in excess of US$30 million. US Venture Partners (USVP) led the round. Participation included new...
IsomAb announces close of £7.5 million financing to accelerate lead candidate...
IsomAb Ltd, a UK-based biotechnology company, has announced the closing of a £7.5 million (approximately US$9.4 million) seed financing round, led by Broadview Ventures, with...
Sensome initiates trial assessing tissue microsensor technology in peripheral arterial disease
Sensome has announced enrolment of the first patients into a feasibility clinical study using the Clotild smart guidewire in peripheral arterial disease (PAD). Clotild was...
‘Get a Pulse on PAD’: Multi-society public awareness campaign launched
The multi-society PAD Pulse Alliance is taking part in a peripheral arterial disease (PAD) public awareness campaign called “Get a Pulse on PAD”.
The group—formed...
UK MHRA update: Paclitaxel-coated device increased mortality risk is withdrawn for...
Following a review, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated guidance on the use of paclitaxel-coated devices stating that such...
AngioDynamics announces US FDA 510(k) clearance of Auryon XL radial access...
AngioDynamics today announced that the US Food and Drug Administration (FDA) has cleared the Auryon XL catheter, a 225cm radial access catheter, for use with...
Summa Therapeutics announce first-in-man injectable angioplasty treatments for PAD
Summa Therapeutics has announced that the first-in-man injectable angioplasty procedures for patients with below-knee peripheral arterial disease (PAD) were performed successfully using its Finesse...
Low-income patients found to receive low-intensity care for CLTI, associated with...
A recent study published in Circulation concerning patients with chronic limb-threatening ischaemia (CLTI) in the USA, has found that patients of low-income status and...
US Centers for Medicare & Medicaid Services grants Transitional Pass-Through payment...
Endologix recently announced that the US Centers for Medicare & Medicaid Services (CMS) has granted a Transitional Pass-Through (TPT) payment for the Detour system,...
Endologix announces results of pooled analysis of DETOUR1 and DETOUR2 Studies...
Endologix has announced results from a pooled analysis of the DETOUR1 and DETOUR2 studies evaluating percutaneous transmural arterial bypass (PTAB) with the Detour system.
A...
LimFlow announces agreement to be acquired by Inari Medical
LimFlow announced today that it has entered into a definitive agreement to be acquired by Inari Medical.
A press release details that, under the terms...
TCT 2023: First presentation of complete patient-level dataset on paclitaxel and...
Data from a patient-level meta-analysis—a factor in the US Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices...
Cardio Flow announces US FDA 510(k) clearance for its FreedomFlow orbital...
Cardio Flow recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow orbital atherectomy peripheral platform.
The company...
Promising future previewed for PAD treatment at Riga summit
This advertorial is sponsored by BD.
There has been major progress in the treatment of peripheral arterial disease (PAD) globally in the last few years,...
FDA update: Paclitaxel-coated devices for PAD cleared of excess mortality risk,...
This advertorial is sponsored by Boston Scientific.
Data on hundreds of thousands of patients who have received lower limb endovascular treatment provide confidence in paclitaxel...
Alucent Biomedical granted US FDA approval for clinical study
Alucent Biomedical has announced that the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) for a US clinical study of...
Endologix announces first patients treated with the Detour system
Endologix has shared in a press release that the first patients underwent percutaneous transmural arterial bypass (PTAB) using the Detour system since US Food...
SVS responds to New York Times article on overuse of vascular...
In an official Society response, SVS president Joseph Mills tackles recent coverage in the mainstream media of inappropriateness in vascular care.
There have been several...
Boston Scientific announces position on FDA update about use of paclitaxel-coated...
Following yesterday's news that the US Food and Drug Administration (FDA) has changed its stance on the use of paclitaxel-coated devices to treat peripheral...
FDA removes red flag for paclitaxel-coated devices after review finds data...
In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA) communicates that the risk of mortality associated...
Black patients nearly 50% less likely to receive revascularisation for PAD
A new study from Keck Medicine at the University of Southern California (USC; Los Angeles, USA) has uncovered “significant racial disparities” in the diagnosis, treatment and outcomes of...
BEST-CLI investigators implore a move beyond endo versus open “battle” in...
The principal investigators behind the BEST-CLI trial struck a conciliatory tone during the inaugural Frank J Veith Distinguished Lecture at this year’s Society for...
Can sirolimus-coated balloons overcome current treatment challenges for chronic limb-threatening ischaemia...
Eric Secemsky (Boston, USA) and Edward Choke (Singapore) discuss the role of sirolimus-coated balloons in the treatment of peripheral arterial disease (PAD), particularly below...
US FDA approves Endologix’s Detour system for treating complex PAD
Endologix has announced in a press release that the US Food and Drug Administration (FDA) has granted approval for the Detour system to treat...
Biotronik launches Oscar multifunctional peripheral catheter at LINC 2023
Biotronik today announced the limited release of its Oscar (One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter and start of promotional activities at this...
Adding 8–12mm diameter devices to the Shockwave Peripheral Intravascular Lithotripsy toolkit
This advertorial is sponsored by Shockwave Medical.
Mazin Foteh, MD, contrasts the benefits of Shockwave Medical’s new Shockwave L6 Peripheral Intravascular Lithotripsy Catheter alongside those...
Vascular News 98 – June 2023 US Edition
In this issue:
Extensive coverage of CX 2023, including a full report of the BASIL-2 randomised controlled trial results
New guidelines: Chris Twine (Bristol, UK)...
Vascular News 98 – June 2023
In this issue:
Extensive coverage of CX 2023, including a full report of the BASIL-2 randomised controlled trial results
New guidelines: Chris Twine (Bristol,...
New “biopsychosocial” roadmap set out to address PAD treatment and mental...
A recent proposal has called for “whole-person, multidisciplinary interventions” after an interrogation of the interplay between lower extremity peripheral arterial disease (PAD) and mental...
Real-world data consistent with RCTs in highlighting the efficacy of drug-eluting...
This advertorial is sponsored by Boston Scientific.
During a recent satellite symposium, which took place at the 2022 Cardiovascular Interventional Radiological Society of Europe (CIRSE)...
BASIL-2 points towards endovascular-first revascularisation strategy in CLTI patients
A question from Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK) on what the Charing Cross (CX) audience should take back to...
Getinge receives US FDA premarket approval for the iCast covered stent...
Getinge's iCast covered stent system has received premarket approval from the US Food and Drug Administration (FDA) for the treatment of patients with iliac...
New VOYAGER PAD analysis confirms consistent benefit of low-dose rivaroxaban plus...
Data from a new prespecified analysis of the phase III VOYAGER PAD clinical trial show that low-dose rivaroxaban plus aspirin resulted in a 33%...
Shockwave IVL: Sound science reinforced by sound evidence
This article forms part of an educational supplement sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
Stefano Fazzini (Tor Vergata Hospital,...
Humacyte publish six-year outcomes in study of HAV for peripheral arterial...
Humacyte, a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced...
“Urgent action needed” to improve implementation of guideline-directed medical therapy for...
Almost one-half of the patients receiving a peripheral vascular intervention (PVI) in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry between...
Jon Boyle
Following his 2021–2022 presidency of the Vascular Society of Great Britain and Ireland (VSGBI), Jon Boyle (Cambridge University Hospitals NHS Trust, Cambridge, UK) speaks...
Patients with claudication receive more “aggressive” surgical management in high-competition regions,...
Demonstrating the “susceptibility” of care delivery to regional market competition, M Libby Weaver (University of Virginia, Charlottesville, USA) presented the case that intermittent claudication...
Concept Medical granted IDE approval for Magic Touch sirolimus DCB below...
The Magic Touch percutaneous transluminal angioplasty (PTA) sirolimus drug-coated balloon catheter (DCB) has received investigational device exemption (IDE) for the treatment of below-the-knee (BTK) atherosclerotic...
Vascular News’ top 10 most popular stories of January 2023
January's top 10 highlights an individual patient data meta-analysis on the safety of carotid endarterectomy in the elderly and a new randomised trial on...
UK NVR annual report highlights “extremely high” case ascertainment rates despite...
The UK National Vascular Registry (NVR) recently published its 2022 annual report—the 10th since the registry was launched in 2013—highlighting important outcome data for...
The BeBack crossing catheter: A “game-changer” in endovascular PAD practice
This advertorial is sponsored by Bentley.
Crossing chronic total occlusion (CTO) lesions are challenging procedures. The BeBack crossing catheter—Bentley’s first product to be available in...
Human-tissue engineered blood vessels remain durable at six years in PAD...
Mid-term results from a phase II study of surgical bypass using the Human Acellular Vessel (HAV; Humacyte) demonstrated an overall secondary patency rate at...
“A very grey area”: EVOCC trial addresses best treatment option for...
Athanasios Saratzis (University of Leicester, Leicester, UK) speaks to Vascular News about the EVOCC trial, which he hopes will dispel patient and physician “uncertainty”...
Cardiovascular Systems enrols first patient in Japan for KAIZEN clinical study
Cardiovascular Systems Inc (CSI) recently announced initiation of the KAIZEN clinical study of its Diamondback 360 peripheral orbital atherectomy system (OAS) for the treatment...
“Impressive” 12-month Flex vessel prep data presented at VEITHsymposium
VentureMed Group, a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of...
Efemoral Medical closes financing round to fund ongoing study of its...
Efemoral Medical has today announced the closing of its US$4.9 million preferred Series A1 round. Supported by existing investors as well as an experienced...
Vascular News’ top 10 most popular stories of November 2022
November's top 10 includes the first results from BEST-CLI, as well as new data presented at this year's Vascular Interventional Advances (VIVA; 31 October–3...
VSGBI President’s Symposium spotlights data-driven financial incentives for PAD revascularisation
The President’s Symposium at the Vascular Society of Great Britain and Ireland (VSGBI) annual scientific meeting (23–25 November, Brighton, UK) featured Rob Sayers’ (University...
VentureMed to present new data on DCB treatment for PAD
VentureMed Group has announced new data presentations on the treatment of peripheral arterial disease (PAD) with drug-coated balloon (DCBs) in addition to 12-month AV...
Chocolate Touch drug-coated angioplasty balloon for treatment of PAD receives FDA...
Genesis MedTech Group announced that the US Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA)...
SIRONA trial enrolment completed
Concept Medical has announced the successful completion of enrolment for the SIRONA randomised controlled trial (RCT) investigating the use of its Magic Touch PTA...
Concept Medical’s SIRONA trial completes enrolment
Concept Medical has announced the completion of patient enrolment in the SIRONA trial. According to the company, this is the world's first and the...
Vascular News’ top 10 most popular stories of September 2022
September's top 10 highlights a randomised trial that aims to examine early endovascular aneurysm repair (EVAR) in women, new radiation safety guidelines from the...
Truveta announces collaboration with Boston Scientific to advance post-procedure patient insights...
Truveta announced a strategic collaborative agreement with Boston Scientific to improve long-term patient care and gain insights into healthcare disparities. Through this collaboration, Boston...
Terumo announces study results underscoring safety and efficacy of radial to...
Terumo Medical Corporation has announced late-breaking data showing the safety and efficacy of radial to peripheral (R2P) interventions with the R2P Misago self-expanding peripheral...
Merit Medical launches the Prelude Roadster guide sheath
Merit Medical Systems has announced the US commercial release of the Prelude Roadster guide sheath. The Prelude Roadster is the newest addition to the...
First US patient enrolled in Selution SLR IDE peripheral study
The first US patient has been enrolled in the US Food and Drug Administration (FDA) SELUTION4BTK (below-the-knee) clinical trial evaluating Selution SLR, MedAlliance's novel...
BD launches first-in-human trial of a peripheral sirolimus drug-coated balloon
BD has announced the start of enrolment in a first-in-human trial of a peripheral sirolimus drug-coated balloon (DCB).
The PREVISION trial is a prospective, multicentre,...
Vascular News’ top 10 most popular stories of July 2022
July's top 10 most popular items include more from this year's Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2022; 15–18 June, Boston,...
AngioDynamics announces FDA clearance of expanded indications for Auryon atherectomy system
AngioDynamics recently announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of an expanded indication for the Auryon atherectomy system...
Selution SLR receives second FDA IDE approval
Selution SLR, MedAlliance's sirolimus-eluting balloon, has received conditional US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical...
First patients enrolled in LIMES randomised trial of Magic Touch sirolimus-coated...
Concept Medical has announced the initiation of the LIMES trial, which has enrolled 15 patients to evaluate the safety and efficacy of the company's...
“No pain, no gain” approach improves walking ability with peripheral arterial...
Walking for exercise at a pace that induced pain or discomfort improved walking ability among people with peripheral arterial disease (PAD), according to new research...
Black adults treated for common arterial disease are at greater risk...
In a study recently published in Circulation, researchers found that Black adults underwent significantly more endovascular peripheral vascular interventions (PVI), were treated for more advanced...
Cordis announces start of enrolment in RADIANCY clinical study in Europe
Cordis has announced the start of the RADIANCY premarket clinical study in Europe.
A press release details that RADIANCY is a prospective, multicentre, single-arm...
New data on Biotronik’s Passeo-18 Lux DCB presented at LINC 2022
Biotronik recently announced the presentation of two studies on the performance of its drug-coated balloon (DCB) catheter Passeo-18 Lux at the Leipzig Interventional Course (LINC)...
New project set to develop nanoparticles with imaging and medicine-delivery capabilities...
A University of Texas at Arlington (UTA; Arlington, USA) bioengineer is leading a project that will develop biodegradable nanomaterials that will take pictures and...
Study demonstrates feasibility, effectiveness of at-home exercise therapy plus cognitive behaviour...
A mobile phone-administered, home-based exercise therapy programme for patients with intermittent claudication (IC) incorporating cognitive behaviour therapy (CBT) was found to be feasible, with...
Shockwave IVL: Maintaining options for patients with calcified PAD
Intravascular Lithotripsy (IVL; Shockwave Medical) gives physicians “the option to treat a patient efficiently without implanting something like a stent, which would limit further...
Researchers report higher three-year amputation and reintervention rates in Black and...
In a study of over 7,000 chronic limb-threatening ischaemia (CLTI) patients, researchers found that Black and Hispanic patients had higher three-year amputation and reintervention...
Shockwave IVL maintains superiority to angioplasty in calcified peripheral disease at...
Shockwave Medical announced today that long-term data from the Disrupt PAD III trial found that superior vessel preparation with intravascular lithotripsy (IVL) led to...
Pounce thrombectomy system first-in-human data show 100% technical success in early...
Surmodics has announced that its Pounce thrombectomy system achieved 100% technical success in 20 first-in-human (FIH) procedures. The FIH data were presented by Gary...
Five-year patient-level data confirm safety of Passeo-18 Lux paclitaxel DCB
New long-term data presented at the 2022 Charing Cross (CX) Symposium (26–28 April, London, UK) demonstrate the safety of Biotronik’s Passeo-18 Lux paclitaxel drug-coated...
Vascular News’ top 10 most popular stories of March 2022
A review of intraoperative adverse events in patients treated with fenestrated and branched endovascular aneurysm repair, meta-analysis findings on peripheral arterial disease symptoms in...
Vascular News – CX Special Edition 2022 US
In this issue:
What to expect from CX 2022
A year in profiles: Ali AbuRahma, Michael Jenkins, Joseph Bavaria, and Palma Shaw
Vascular News debuts a...
Vascular News – CX Special Edition 2022 OUS
In this issue:
What to expect from CX 2022
A year in profiles: Ali AbuRahma, Michael Jenkins, Joseph Bavaria, and Palma Shaw
Vascular News...
Data from new VOYAGER PAD analyses reinforce benefit of Xarelto plus...
The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the...
New Janssen initiative aims to advance equitable care and address hidden...
Janssen has announced the launch of 'Save Legs. Change Lives. Spot Peripheral Artery Disease Now', a multi-year initiative aimed at creating urgency and action...
Ra Medical Systems reaches 100 enrolled subjects in pivotal atherectomy clinical...
Ra Medical Systems has announced the achievement of a milestone with the enrollment of 100 subjects in the pivotal clinical study, according to a...
Peripheral arterial disease symptoms differ between sexes, meta-analysis finds
In future peripheral arterial disease (PAD) research, clinicians should not consider men and women as a single population and should instead report their data...
PROMISE II US pivotal trial of device designed for “no-option” CLTI...
Enrolment has been completed in the PROMISE II pivotal trial of the LimFlow deep vein arterialisation system (LimFlow SA) designed to prevent amputations in...
Ra Medical Systems provides update on enrolment in pivotal atherectomy clinical...
Ra Medical Systems recently announced that enrolment has reached 95 patients in its pivotal clinical trial to evaluate the safety and effectiveness of the...
SIRONA head-to-head randomised trial achieves 50% enrolment
Concept Medical recently announced that the SIRONA randomised controlled trial (RCT)—a head-to-head comparison of sirolimus versus paclitaxel drug-eluting balloon angioplasty in the femoropopliteal artery—has...
MedAlliance acquires Japanese partner MDK Medical
MedAlliance has acquired its partner MDK Medical, a Japanese vascular specialist company. MDK Medical has previously worked closely with MedAlliance in developing Japanese clinical...
Humacyte’s Human Acellular Vessel for limb salvage evaluated in multiple complex...
Humacyte today announced results from the first series of compassionate use cases of the company’s investigational Human Acellular Vessel (HAV) for the treatment of...
Cook Medical receives FDA breakthrough designation for new drug-eluting stent
Cook Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) on a new drug-eluting stent for below the knee...
Cardiovascular Systems announces development of IVL technology for the treatment of...
Cardiovascular Systems recently announced that it has made significant progress towards the commercialisation of intravascular lithotripsy (IVL) systems for the treatment of calcific coronary...
VOYAGER PAD subanalysis highlights risks for claudicants undergoing revascularisation
Principal investigator of the VOYAGER PAD trial, Marc Bonaca (University of Colorado Anschutz Medical Campus, Aurora, USA) speaks to Vascular News about the latest data...
Endologix names Matthew Thompson president and CEO
Endologix has announced the appointment of Matthew Thompson as president and chief executive officer. Thompson will also join Endologix’s board of directors. Richard Mott,...
Hispanic adults with PAD access inpatient care most often via the...
Hispanic adults hospitalised for treatment of symptoms of peripheral arterial disease (PAD) were more likely to access this care by going to the emergency...
Head-to-head trial shows superiority of FemoSeal over ProGlide for peripheral interventions
Results of the randomised, prospective, multicentre STEP trial show that the FemoSeal vascular closure system (Terumo) is superior to the Perclose ProGlide suture-mediated closure...
Two-year Ranger DCB data demonstrate “sustained, high rate” of device efficacy
Patients treated with the Ranger drug-coated balloon (DCB; Boston Scientific) sustained “improved primary patency” with fewer reinterventions than those treated with uncoated devices, two-year...
VIVA 2021: IVL “consistently” treats real-world calcium in multiple peripheral vessel...
An interim analysis from the DISRUPT PAD III observational study showed that intravascular lithotripsy (IVL; Shockwave Medical) performs “consistently well” across challenging peripheral vessels,...
One-year results show “superior” primary patency rate for Eluvia DES compared...
One-year results presented at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA) from the EMINENT trial demonstrated the superiority of the Eluvia...
VIVA 2021: Consensus established for appropriate use of IVUS in peripheral...
A worldwide committee of 40 cross-speciality medical experts achieved the first-ever consensus for the appropriate use of intravascular ultrasound (IVUS) in peripheral vascular disease...
First patient treated with Cardiovascular Systems’ ViperCross peripheral support catheter
Cardiovascular Systems recently announced that the first patient has been successfully treated with its ViperCross peripheral support catheter.
Billy J Kim (The Surgical Clinic, Nashville,...
First patient enrolled in BIONETIC-I study of iliac artery treatment with...
Biotronik has announced the first patient enrolment in the BIONETIC-I study of the safety and efficacy of the Dynetic-35 cobalt chromium balloon-expandable stent system...
Japanese Selution SLR study completes enrolment
MedAlliance, with its Japanese partner MDK Medical, has completed enrolment in the clinical study of its novel sirolimus drug-eluting balloon (DEB), Selution SLR, for...
Vascular News’ top 10 most popular stories of August 2021
Research presented at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online)—including new VOYAGER PAD...
CardioVascular Coalition urges Congress, CMS to reverse proposed Medicare cuts during...
The CardioVascular Coalition (CVC), a group of physicians, care providers, advocates, and manufacturers working to improve awareness and prevention of peripheral arterial disease (PAD),...
Amputation rates higher for people with PAD who are poor or...
Poverty and Black race were associated with higher rates of lower leg amputation among people with peripheral arterial disease (PAD) who live in metropolitan areas, according...
FDA approves expanded PAD indication for Xarelto plus aspirin to include...
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the US Food and Drug Administration (FDA) has approved an expanded peripheral arterial...
VOYAGER PAD: Rivaroxaban plus aspirin should be considered after lower extremity...
“A strategy of adding rivaroxaban 2.5mg twice daily to aspirin should be considered after lower extremity bypass regardless of conduit type,” concluded Nicholas Govsyeyev...
Research letter highlights low adoption of supervised exercise therapy for PAD
A research letter published in Circulation: Cardiovascular Quality and Outcomes highlights a “very low” utilisation of supervised exercise therapy (SET) in symptomatic peripheral arterial...
AHA scientific statement provides update on epidemiology, diagnosis, and management of...
The American Heart Association (AHA) has released a new scientific statement on lower extremity peripheral arterial disease (PAD), focusing on contemporary epidemiology, management gaps,...
Researchers recommend “timely interventions by specialists and guideline-based treatment” to reduce...
A population-based study from 2013 to 2015 in Germany has found that nearly one fifth of patients with peripheral arterial disease (PAD) did not...
Case report: Recanalisation of chronic iliofemoral venous occlusion in a patient...
This advertorial, sponsored by BD, is only available in selected countries and geographies.
In this case report for Vascular News, experts outline the importance...
Nationwide study identifies sex disparities in long-term mortality after paclitaxel exposure
A German claims-based cohort study has revealed that—in 13,204 patients treated with a paclitaxel-coated device for peripheral arterial disease (PAD)—mortality differences were mostly attributable...
Vascular News’ top 10 most popular stories of June 2021
New data from Philips' TOBA II below-the-knee (BTK) clinical trial, physicians' call for the AMPREDICT decision support tool to be applied in clinical practice,...
Femoropopliteal bypass shows reintervention benefit over endovascular therapy for advanced premature...
Femoropopliteal bypass is associated with decreased reinterventions at one year compared to endovascular therapy in patients with advanced premature peripheral arterial disease (PAD). This...
ACC 2021: VOYAGER-PAD analysis shows totality of ischaemic events reduced following...
Rupert Bauersachs (Darmstadt, Germany) talks to Cardiovascular News about the VOYAGER-PAD trial, the results of which he presented at the American College of Cardiology’s...
XO Score scoring sheath platform wins medical design award
Transit Scientific today announced that its XO Score scoring sheath platform has been named a winner in the 2021 Medical Design Excellence Awards (MDEA)....
Concept Medical releases status updates on SIRONA RCT
Concept Medical has released a series of status updates on their head-to-head SIRONA (Sirolimus versus paclitaxel drug-eluting balloon angioplasty in femoropopliteal diseases) randomised controlled...
PAD Task Force commends reintroduction of ARC Act in the USA...
Members of the peripheral arterial disease (PAD) Task Force—including the Association of Black Cardiologists (ABC), CardioVascular Coalition, CLI Global Society, Preventative Cardiovascular Nurses Association,...
Micro Medical Solutions receives FDA breakthrough device designation for MicroStent vascular...
Micro Medical Solutions (MMS) recently announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its MicroStent vascular stent....
Micro Medical Solutions receives FDA breakthrough device designation for MicroStent vascular...
Micro Medical Solutions (MMS) recently announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its MicroStent vascular stent....
Introduction of dedicated vascular limb salvage clinic improves one-year amputation outcomes...
One-year outcomes of patients with chronic-limb threatening ischaemia (CLTI) treated in an outpatient-based vascular limb salvage clinic show an improved rate of major amputation....
Novel PAD treatment may be more cost-effective than standard care, study...
FlowOx therapy (Otivio) delivered as a single annual dose may be a cost-effective treatment for peripheral arterial disease (PAD), a recent study published in...
Acute kidney injury is associated with medium-term mortality following endovascular intervention...
Acute kidney injury is a common complication after intervention for peripheral arterial disease (PAD), and is associated with “medium-term mortality” following percutaneous transluminal angioplasty...
Soundbite announces Health Canada approval for SoundBite crossing system – Peripheral...
Soundbite Medical Solutions has announced Health Canada approval for the SoundBite Crossing System – Peripheral (SCS-P) with the 0.014” Active Wire (14P).
The SCS-P (14P)...
CONSEQUENT study shows low mortality and TLR rates in PAD patients...
NOTE: This video is ONLY available to watch in selected countries and geographies
Ralf Langhoff (Berlin, Germany) talks to Vascular News about the 12-month...
Soundbite announces Health Canada approval for SoundBite crossing system – Peripheral...
Soundbite Medical Solutions has announced Health Canada approval for the SoundBite Crossing System – Peripheral (SCS-P) with the 0.014” Active Wire (14P).
The SCS-P (14P)...
LINC 2021: PRELUDE-BTK results confirm Serranator device novel mechanism of action
Cagent Vascular announced the results of its PRELUDE-BTK study at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online). The PRELUDE-BTK study was a...
SVS Foundation’s new initiative to address disparities in vascular health
Significant disparities in healthcare services in the USA result in unnecessary limb loss, stroke, and death. Vascular health professionals are developing new programmes to...
Walking can relieve leg pain in people with peripheral arterial disease
Exercise can play an important role in treating peripheral arterial disease (PAD), a recent review from Amy Harwood (Centre for Sport and Exercise Life...
Infinity angioplasty balloon catheter completes first-in-human clinical trial
The Infinity Angioplasty Balloon Company announced today that its angioplasty balloon platform—the Infinity angioplasty balloon catheter—has successfully completed a first-in-human clinical trial.
The platform was...
RCT investigating use of MagicTouch PTA sirolimus-coated balloon for PAD enrols...
Concept Medical has announced the enrolment of the first patient in the SirPAD (Sirolimus in peripheral arterial disease) trial. According to a press release,...
Boston Scientific receives FDA approval for the Ranger DCB
Boston Scientific announced it has received US Food and Drug Administration (FDA) approval of the Ranger drug-coated balloon (DCB), developed for the treatment of...
Ra Medical Systems announces 10 subjects have been enrolled in its...
Ra Medical Systems has announced enrolment of the tenth subject in its pivotal clinical trial to evaluate the safety and effectiveness of the Dabra...
R3 Vascular completes Series A financing
R3 Vascular recently announced closing of its Series A financing round, including new equity investments of US$15 million and the conversion of US$2.8 million...
CIRSE 2020: New clinical data support use of 4F devices for...
Outcomes of the BIO4AMB trial demonstrated that ambulatory treatment with 4-French (4F) devices is a valid and safe option for endovascular treatment of lower...
First patient enrolled in FUTURE SFA study of MagicTouch sirolimus-coated balloon
Concept Medical has announced the enrolment of the first patient in the FUTURE SFA (Randomised controlled trial of first sirolimus coated balloon versus standard...
CMS grants additional reimbursement for the Eluvia drug-eluting vascular stent system
Boston Scientific announced that the US Centers for Medicare and Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for the Eluvia drug-eluting...
PQ Bypass receives FDA breakthrough device designation for its Detour system
PQ Bypass has announced that they received breakthrough device designation from the US Food and Drug Administration (FDA) for the Detour system. The Detour...
Philips to expand its image-guided therapy portfolio through acquisition of Intact...
Royal Philips today announced that it has signed an agreement to acquire Intact Vascular. According to a press release, Intact Vascular will enhance Philips’...
High level of heterogeneity found in randomised PAD trial antithrombotic regimens
A recent systematic review showed that randomised trials comparing different types of peripheral endovascular arterial intervention have a high level of heterogeneity in their...
First patient enrolled in PATHFINDER I registry examining Auryon atherectomy system
AngioDynamics has announced the enrolment of the first patient in the PATHFINDER I postmarket registry.
The PATHFINDER I registry is a pilot study to evaluate...
PRIZER, new multicentre PAD study, launches
A new post-market study investigating the effectiveness of the Renzan peripheral stent system (Terumo) in patients with peripheral arterial disease (PAD) has been...
SVS pilots SET app for peripheral arterial disease patients
Doctor-prescribed and -supervised exercise therapy is going digital. The Society for Vascular Surgery (SVS) will begin piloting a ground-breaking app for Supervised Exercise Therapy...
SVS International Lecture: Endovascular pioneer discusses new PAD therapy
A new therapy of hydration and oncotic pressure of plasma helped 100% of certain elderly peripheral artery disease (PAD) patients in terms of pain,...
MHRA: Warning to be added to paclitaxel device IFUs in Europe
In a new field safety notice, the UK Medicines and Healthcare products Regulatory Agency (MHRA) states that a warning and clinical summary section will...
Wingman catheter granted expanded indication to cross CTOs in PAD
Reflow Medical has announced that they have received US Food and Drug Administration (FDA) clearance for an expanded indication for the Wingman crossing catheter...
Real-time tissue perfusion device can assess re-establishment of blood flow to...
Paul Hayes (Cambridge, UK) talks to BLearning Wounds at LINC 2020 (Leipzig Interventional Course; 28–31 January 2020, Leipzig, Germany) about the challenges of wound...
Profusa wins CE mark approval for real-time tissue oxygen monitoring platform
Profusa has announced that it has received Conformité Européenne (CE) mark approval to market its Wireless Lumee Oxygen platform for continuous, real-time monitoring of...
CMS approves coverage for PQ Bypass TORUS 2 IDE trial
PQ Bypass announced today that it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the Investigational Device...
ESC/ESVS consensus document gives clear recommendations for following up patients after...
New guidance on monitoring patients after revascularisation for peripheral arterial diseases (PAD) has been produced by the European Society of Cardiology (ESC) Working Group...
CIRSE 2019: Hear the latest from clinical trials comparing paclitaxel technologies...
NOTE: ONLY intended for healthcare professionals outside of the USA and France.
Zoom in on a tête-à-tete between Marianne Brodmann (Graz, Austria) and Giovanni Torsello...
Statins linked with reduced mortality in PAD patients, even when started...
Statins are linked with reduced mortality in patients with peripheral arterial disease, even when started late after diagnosis, reports a study presented recently at...
New study points to SFDI as promising technology for assessing patients...
New evidence supports the utility of spatial frequency domain imaging (SFDI) for identifying compromised circulation in patients at risk of peripheral arterial disease (PAD)....
CX 2019: Evidence supports safety of paclitaxel-coated devices
At the Charing Cross International Symposium, Gary Ansel (Columbus, Ohio) moderates a global panel that includes Thomas Albrecht (Berlin, Germany), Peter Schneider (San Francisco,...
Depression and peripheral arterial disease: A call to action
With “an indisputable association between depression and peripheral arterial disease (PAD)”—nearly a third of PAD patients experience comorbid depression or depressive symptoms—Joel Ramirez and...
Customising therapy in femoropopliteal revascularisation
Gary Ansel (Columbus, USA) tells Vascular News at VEITHSymposium 2018 about how drug-based therapies have become a mainstay in femoropopliteal revascularisation and how interventionalists...
Identifying and repairing dissections that matter
Marianne Brodmann (Graz, Austria) quizzes Michael Lichternberg (Arnsberg, Germany) at LINC 2019 on his choice of tools to identify and repair dissections in both...
Smoking cigarettes associated with increased risk of peripheral arterial disease in...
African Americans who smoke cigarettes are more likely than those who do not smoke to develop peripheral arterial disease (PAD), according to new research...
Smoking cigarettes associated with increased risk of peripheral arterial disease in...
African Americans who smoke cigarettes are more likely than those who do not smoke to develop peripheral arterial disease (PAD), according to new research...
PCSK9 inhibitors, rivaroxaban and a diabetes drug are major milestones in...
Michael Jaff (Newton, USA) outlines the major recent developments in best medical therapy that will impact the treatment of peripheral arterial disease (PAD) at...
Lutonix BTK IDE: First Level 1 evidence of positive safety and...
Patrick Geraghty (St Louis, USA) presented new datapoints from the six-month outcomes of the Lutonix BTK IDE trial at the 2018 VEITHsymposium (13–17 November,...
Lutonix 014 DCB gathers first randomised evidence of positive safety and...
Six-month outcomes of the Lutonix BTK IDE trial, a multicentre randomised controlled trial using the Lutonix 014 drug-coated balloon (DCB; BD), has demonstrated that...
Similar patency outcomes in women and men treated with Stellarex DCB
A study presented at VIVA 2018 (5–8 November, Las Vegas, USA) by Maureen Kohi, associate professor of Clinical Radiology, University of California, San Francisco,...
IN.PACT SFA Trial five-year data and Total IN.PACT All-Subjects analysis presented...
The five-year and final results from the pivotal IN.PACT SFA Trial and one-year all-subjects results from the Total IN.PACT Pooled Analysis of the IN.PACT...
Consider intravascular lithotripsy when treating calcified femoropopliteal arteries
Treating severely calcified arteries by endovascular means is still a challenge, although atherectomy, stents and lithotripsy are all techniques that are employed. Lithotripsy (also...
Eximo Medical receives FDA clearance for B-Laser atherectomy system to treat...
Eximo Medical has announced it has received 510(k) clearance from the US Food & Drug Administration (FDA) for its B-Laser atherectomy system for peripheral...
Peripheral arterial disease patients at increased risk for high opioid use
Patients with peripheral arterial disease (PAD) are found to have an increased risk for high opioid use. Nathan Itoga and colleagues from the University...
HART PAD blood test accurately diagnoses peripheral arterial disease in diabetic...
Prevencio has announced data demonstrating its HART PAD test accurately diagnoses peripheral arterial disease (PAD) in diabetes mellitus patients, a patient population in which...
First-ever CE mark of a bioresorbable scaffold for below-the-knee PAD
Reva Medical, a company developing bioresorbable polymer technologies for vascular applications, has announced that its Motiv bioresorbable scaffold is the first drug-eluting bioresorbable scaffold...
Ra Medical files statement for proposed initial public offering
Ra Medical Systems has filed a registration statement on Form S-1 with the US Securities and Exchange Commission relating to a proposed initial public...
Terumo gets CE mark for Kanshas drug-coated balloon catheter for lower...
Terumo has announced that it acquired CE mark for the Kanshas drug-coated balloon catheter used in the treatment of lower extremity peripheral arterial disease....
Medtronic receives US FDA clearance for 200mm and 250mm IN.PACT Admiral...
Medtronic has announced that it has received US FDA approval for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) to treat...
LIBERTY 360 18-month outcomes presented at CRT
Cardiovascular Systems Inc (CSI) presented 18-month outcomes from its LIBERTY 360 study at the Cardiovascular Research Technologies (CRT; 3-6 March, Washington, DC, USA). The...
US FDA clears CorPath GRX system for use in peripheral vascular...
Corindus has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) for use of the CorPath GRX system in peripheral vascular...
LimFlow completes enrolment in US feasibility study
LimFlow has announced completion of enrolment of the original 10-patient cohort in the US feasibility study of the LimFlow percutaneous deep vein arterialisation system....
LINC 2018 data highlight IN.PACT Admiral as safe and effective treatment...
Medtronic added to its body of clinical evidence supporting the IN.PACT Admiral drug-coated balloon with new presentations that demonstrated durable and consistent clinical outcomes...
Hyperspectral imaging for assessing regional foot perfusion
There has been significant progress in limb salvage in patients with peripheral artery disease (PAD) and critical limb ischaemia (CLI) over the past two...
PAD catheter effective in all lesion types receives FDA clearance
XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the US Food and Drug Administration...
First patients treated with Avinger’s next generation atherectomy device
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the first use of their next generation Pantheris lumivascular atherectomy system. The...
PQ Bypass receives IDE approval to initiate pivotal DETOUR II clinical...
PQ Bypass has received conditional approval of its investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate the pivotal...
Janssen submits application for new Xarelto (rivaroxaban) indications for CAD and...
Janssen has submitted a supplemental new drug application to the US Food and Drug Administration (FDA) for two new Xarelto (rivaroxaban) vascular indications: reducing the...
Xarelto (rivaroxaban) reduces risk of major amputation by 70% in peripheral...
Bayer and its cooperation partner Janssen Research & Development have announced two publications of further data from the Phase III COMPASS study in The...
Serranator PTA serration balloon catheter receives CE mark
Cagent Vascular has announced the issuance of its CE marking for the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter. Cagent Vascular has also achieved...
New Global Vascular Guidelines for chronic limb threatening ischaemia
At the European Society for Vascular Surgery (ESVS) meeting (19–22 September, Lyon, France), Vascular News spoke to Florian Dick (University of Bern, Bern, Switzerland)...
FDA 510(k) clearance for Nitiloop’s Nova Cross Extreme and Nova Cross...
Nitiloop has received FDA clearance for its new Nova Cross Extreme and Nova Cross BTK. According to the company, these dedicated microcatheters are joining the Nova Cross product family “combining...
Mercator announces completion of enrolment in LIMBO-ATX
Mercator MedSystems has announced completion of enrolment in the company’s LIMBO-ATX (Lower-limb adventitial infusion of dexamethasone via Bullfrog to reduce occurrence of restenosis after...
First patient enrolled in IDE study of the Pantheris system for...
Avinger has announced initiation of INSIGHT, a prospective, global, single arm, multicentre study to evaluate the safety and effectiveness of the Pantheris Lumivascular Atherectomy...
Phase I/II SHIELD trial results with SB-030 in peripheral vascular disease...
Symic Bio has announced results from the phase I/II SHIELD trial evaluating SB-030, a locally administered therapeutic, in patients with peripheral vascular disease undergoing...
Depression and peripheral artery disease: The intersectionality of mental and physical...
Over the past few years, we have seen an increased awareness of the role of mental health in several health outcomes, note Marlene Grenon and...
Patient adherence, funding and physician interest remain barriers to supervised exercise...
The US Centers for Medicare and Medicaid Services (CMS) has determined that there is now sufficient evidence to cover supervised exercise therapy for the...
BTG acquires Roxwood Medical
BTG today announces it has acquired Roxwood Medical, an innovative provider of advanced cardiovascular specialty catheters used in the treatment of patients with severe...
New analysis suggests peripheral artery disease affects 42–60 million Chinese citizens
A new analysis published by The Sage Group has concluded that 42–60 million Chinese citizens are afflicted by peripheral artery disease (PAD), with 5.6–6.3...
Shockwave Medical reports positive results for Lithoplasty in calcified lesions below...
Shockwave Medical has reported positive results from the DISRUPT BTK Study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe...
Luminor EffPAC study shows efficacy at six months
Data have been announced demonstrating the efficacy of iVascular’s Luminor drug-coated balloon (DCB) in patients with peripheral artery disease (PAD) at six months. The...
Lesion preparation using Diamondback 360 orbital atherectomy enhances paclitaxel distribution in...
CBSET, a not-for-profit preclinical research institute dedicated to translational research, education, and advancement of medical technologies, has announced that its scientists have published data...
Two-year efficacy of Philips’ Stellarex 0.035” low-dose drug-coated balloon demonstrated
Philips has announced the two-year results from the ILLUMENATE European randomised clinical trial (EU RCT) demonstrating the efficacy of the Philips Spectranetics’ Stellarex 0.035”...
Two- and four-year IN.PACT Admiral drug-coated balloon data indicate good mid-...
Medtronic has released data reinforcing the durability and safety of the IN.PACT Admiral drug-coated balloon (DCB) in patients with peripheral artery disease (PAD). The...
New Mimics data support use of the BioMimics 3D swirling flow...
New significant outcomes from the Mimics study have been presented at the 15th annual conference on Vascular Interventional Advances (VIVA; 11-14 September, Las Vegas,...
Contego Medical announces ENTRAP Study initiation for Vanguard IEP peripheral balloon...
Contego Medical has announced the initiation of the ENTRAP Study evaluating usage of its Vanguard IEP peripheral balloon angioplasty system with integrated embolic protection...
IN.PACT Admiral drug-coated balloon is approved in Japan
Medtronic announced on 8 September 2017 that the IN.PACT Admiral drug-coated balloon (DCB) received approval from the Japanese Ministry of Health, Labour and Welfare...
Gardia Medical demonstrates enhanced safety in lower extremity interventions
Gardia Medical has announced that, according to the independent Clinical Events Committee (CEC), the company has successfully met the primary endpoint in its WISE-LE...
ESC publishes new guidelines on the diagnosis and treatment of peripheral...
European Society of Cardiology (ESC) Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, developed in collaboration with the European Society for Vascular...
Full US availability of Biotronik Pulsar-18 self-expanding stent announced
Getinge has announced the full US market release of the Pulsar-18 stent from Biotronik. Pulsar-18 is the only available self-expanding stent for blocked superficial...
Outpatient atherectomy outcomes may be “worse than natural history of disease”
Atherectomy for occlusive disease in the femoral-popliteal and tibial-peroneal segments for claudication in outpatient settings may result in outcomes worse than the natural history...
Surmodics receives IDE approval to initiate SurVeil drug-coated balloon pivotal trial
Surmodics has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the...
Spectranetics announces FDA approval of Stellarex drug-coated balloon
Spectranetics has announced receipt of US Food and Drug Administration (FDA) pre-market approval of the Stellarex drug-coated balloon (DCB), designed to restore and maintain blood flow...
Ra Medical Systems granted broad patent for DABRA catheter
The US Patent and Trademark Office has granted Ra Medical Systems a broad patent (number 9700655) that covers Ra Medical Systems’ DABRA catheter for...
IN.PACT Admiral approved for reimbursement in France and Belgium
Medtronic has announced recent reimbursement approvals in both France and Belgium.
A Ministerial decree was published in the Official Journal of French Republic to enlist...
Cagent Vascular announces FDA 510(k) clearance of Serranator Alto serration balloon...
Cagent Vascular has announced US Food and Drug Administration 510(k) clearance of its lead product, the Serranator Alto percutaneous transluminal angioplasty serration balloon catheter. The Serranator...
Japanese IN.PACT SFA study demonstrates clinical outcomes consistent with other trials
The one-year clinical outcomes from the MDT-2113 IN.PACT SFA Japan trial have been released. The data was recently presented by Osamu Iida, Kansai Rosai...
Cardiovascular Systems signs distribution agreement with Medikit for Japan
Cardiovascular Systems has signed an exclusive distribution agreement with Medikit to sell its Diamondback 360 Coronary and Peripheral Orbital Atherectomy Systems (OAS) in Japan.
According to...
LEG-DEB registry reports encouraging six-month interim analysis for LegFlow
Six-month interim analysis of the Legflow drug-eluting balloon for the treatment of femoropopliteal occlusions (LEG-DEB) registry indicates that “the use of a new generation...
SUPERFAST results show advantage of Supera for chronic total occlusions
New data from a propensity matched prospective study suggest the Supera stent (Abbott Vascular) delivers superior results when compared to older generation nitinol stents...
Medtronic receives FDA clearance of new lower profile HawkOne 6F directional...
Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for the HawkOne Directional Atherectomy System in a new size for treating...
Enrolment completed in the MIMICS-2 study
Veryan Medical has announced completion of patient enrolment in the MIMICS-2 clinical study of its BioMimics 3D self-expanding stent system (BioMimics 3D), which features...
Akesys and Elixir announce first human implant of the Prava bioresorbable...
Akesys Medical has announced their first clinical trial and successful implant of the Prava sirolimus-eluting bioresorbable peripheral scaffold system for the treatment of blockage...
Shockwave Medical Lithoplasty system is cleared by the FDA
Shockwave Medica has announced clearance from the US Food and Drug Administration (FDA) of the Lithoplasty system for the treatment of calcified plaque in...
First patient enrolled in the MIMICS-3D registry
Veryan Medical has announced that the first patient has been enrolled into the company-sponsored MIMICS-3D registry by Michael Lichtenberg, Arnsberg, Germany. MIMICS-3D is a...
EUCLID trial to analyse monotherapy of ticagrelor versus clopidogrel in patients...
Despite “overwhelming data” demonstrating the efficacy of antiplatelet therapy in heart disease and stroke, data for antiplatelet therapy for peripheral arterial disease (PAD) are...
Cardiovascular Systems releases 30-day results from LIBERTY 360° study
Cardiovascular Systems has released procedural and 30-day results from its LIBERTY 360° study in a late-breaking presentation at the 2016 Amputation Prevention Symposium (AMP;...
TOBA study results demonstrate 76.4% 12-month primary patency and 89.5% freedom...
The one-year results from Intact Vascular’s Tack Optimized Balloon Angioplasty (TOBA) clinical study have been published in the Journal of Vascular Surgery.
The TOBA study...
First randomised Stellarex DCB data show 12-month outcomes superior to percutaneous...
Marianne Brodmann of Medical University Graz, Austria, has presented the final 12-month results of the Stellarex (Spectranetics) ILLUMENATE drug-coated balloon European randomised clinical trial...
Gore Tigris vascular stent gains FDA approval for treatment of peripheral...
Gore has announced US Food and Drug Administration (FDA) approval of the Gore Tigris vascular stent, a dual-component stent with a unique fluoropolymer/nitinol design....
REALITY trial enrols first patient in study evaluating Medtronic directional atherectomy...
Medtronic and VIVA Physicians reported on 27 July 2016 the first patient enrolled in the REALITY Study. The VIVA-sponsored study is assessing outcomes for...
UK NICE publishes Medtech Innovation Briefing on Lutonix
The UK National Institute for Health and Care Excellence (NICE) has developed a Medtech Innovation Briefing (MIB) on the Lutonix drug-coated balloon (DCB) for...
Promising findings for novel drug-eluting peripheral stent
A new animal study, presented at EuroPCR (17–20 May, Paris), indicates that a novel, fluoropolymer-coated, self-expanding, paclitaxel-eluting peripheral stent (Eluvia, Boston Scientific) is associated...
