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“If we are going to use these devices, we have to use them correctly”:...
Delivering first-release data, Scott O Trerotola (University of Pennsylvania, Philadelphia, USA) conveyed the “consistent results” in a real-world environment for the Lutonix arteriovenous (AV)...
Case report: Recanalisation of a long SFA occlusion with Ultrascore™ Focused Force PTA Balloon...
This advertorial, sponsored by BD, is only available in selected countries and geographies.
“Improving vessel compliance with focused force longitudinal plaque fracture seems to...
FDA advisory panel recommends against premarket approval of Lutonix 014 DCB for BTK use
A US Food and Drug Administration (FDA) advisory panel has recommended against premarket approval of BD’s Lutonix 014 drug-coated balloon (DCB) for use in...
Six-month results of Lutonix AV Global registry published
Six-month results of the Lutonix arteriovenous (AV) Global registry were recently published in the Journal of Vascular and Interventional Radiology (JVIR). The data confirm...
FDA notifies BD that Lutonix paclitaxel balloon PMA application for below the knee “not...
The US Food and Drug Administration (FDA) have denied BD premarket approval (PMA) for the company’s Lutonix drug-coated balloon (DCB) in the treatment of...
FDA notifies BD that Lutonix paclitaxel balloon PMA request for below the knee “not...
The US Food and Drug Administration (FDA) have denied BD premarket approval (PMA) for the company’s Lutonix drug-coated balloon (DCB) in the treatment of...
ULTRASCORE scoring helps obtain luminal gain at low inflation pressure before Lutonix DCB use
Dierk Scheinert (Leipzig, Germany) talks to Vascular News at LINC 2019 about the importance of vessel preparation with adjunctive therapies such as the use...
Lutonix BTK IDE: First Level 1 evidence of positive safety and efficacy for DCB...
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 efficacy when used...
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...
Lutonix BTK randomised trial meets safety and efficacy endpoints at six months
Six-month outcomes of a multicentre randomised controlled trial using the Lutonix 014 drug-coated balloon (BD; DCB) has demonstrated the DCB is safe to use...
Lutonix Global AV Registry: DCB use prolongs time to reintervention in failing arteriovenous access
Tobias Steinke (Dusseldorf, Germany) reported on the Lutonix Global arteriovenous (AV) Registry at CIRSE 2018 in Lisbon, Portugal. Lutonix Global AV Registry data add to...
First look at the interim LUTONIX DCB AV registry data
Vascular News interviews Panos Kitrou, Patras University Hospital, Rio, Greece, on the interim data from the LUTONIX DCB AV registry trial. The data were presented...
BD announces completion of enrolment in Lutonix 014 DCB below-the-knee trial
Enrolment is complete in the Lutonix below-the-knee trial with BD planning to submit a pre-market approval application to the US Food and Drug Administration...
Bard gets FDA premarket approval of the Lutonix 035 DCB for dysfunctional AV fistulae
Bard’s Lutonix 035 drug-coated balloon PTA catheter (DCB) has been granted premarket approval (PMA) by the US Food and Drug Administration (FDA) for a...
Lutonix for dysfunctional arteriovenous fistulae shows improved primary patency vs. plain balloon angioplasty at...
Interim twelve-month data from the Lutonix AV Clinical Trial indicate that treatment of dysfunctional arteriovenous (AV) fistulae with Bard’s Lutonix drug-coated balloon (DCB) produces...
Lutonix AV results provide tailwind for drug-coated balloons in dysfunctional arteriovenous fistula treatment
Scott Trerotola presented the first release of eight-month data from the Lutonix AV trial at the Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany)...
Promising early results for Lutonix US IDE trial in obstructed AV fistulae
The first US randomised controlled trial for drug-coated balloon use for arteriovenous fistula obstructions for 50 years, the Lutonix (Bard) IDE trial was a...
Lutonix Global Real-World Registry 24-month outcomes presented at VIVA 2016
Bard has announced the presentation of the final 24-month results from the Lutonix Global Real-World Registry at the Vascular Intervention Advances (VIVA) 2016 meeting...
FDA approves six-month primary endpoint for the Lutonix below-the-knee drug-coated balloon
The US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint to a six-month...
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...
Real-world comparison shows similar efficacy between Bard Lutonix and Medtronic IN.PACT drug-coated balloons
Results presented at LINC 2016 revealed no significant difference at 18 months in target lesion revascularisation and sustained clinical improvement between the Lutonix and the IN.PACT drug-coated balloons. Clinical improvement was measured by improvement in Rutherford class from baseline or prior to drug-coated balloon treatment.
Lutonix Global Real-World Registry outcomes presented at TCT 2015
The presentation of the 12-month results from the Lutonix Global Real-World Registry at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 meeting has been announced by C....
CMS approves add-on payment for Lutonix drug-coated balloon for inpatient use
The purpose of the reimbursement is to help cover additional cost to US hospitals for treating Medicare beneficiaries with Lutonix in the inpatient setting.
Medicare approves pass-through payment for Lutonix drug-coated balloon for outpatient use
The purpose of the supplemental reimbursement is to cover additional cost to US hospitals for treating Medicare beneficiaries with Lutonix in the outpatient setting.
Boston Scientific and Bard announce distribution agreement for Lutonix
Agreement extends reach of Lutonix drug-coated balloon to prepare and treat diseased femoropopliteal vessels.
Low-dose Lutonix drug-eluting balloon shows lower late lumen loss than plain angioplasty at six...
Treatment of femoropopliteal lesions with the device reduces late lumen loss with safety comparable to that of control angioplasty, according to LEVANT I trial results published in JACC: Cardiovascular Interventions.
Bard acquires Lutonix
Bard has acquired Lutonix for a purchase price of approximately US$225 million paid at closing, with an additional US$100 million to be paid upon US premarket approval of Lutonix's drug-coated percutaneous transluminal angioplasty balloon.
Lutonix receives CE mark and FDA approval to initiate pivotal IDE drug-coated balloon trial
LEVANT 2 is a global, multicentre, randomised study evaluating the safety and efficacy of the Moxy drug-coated balloon compared to standard angioplasty.
ABISS trial comparison finds DCB superior to plain-balloon angioplasty in per-protocol analysis
Data have been presented for the first time at the Paris Vascular Insights (PVI) conference (23–25 November, Paris, France) from the ABISS trial, which...
Chocolate Touch drug-coated angioplasty balloon for treatment of PAD receives FDA approval
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)...
IN.PACT AV Access: Three-year data support use of paclitaxel-coated balloon as “standard of care”...
The 36-month results from the IN.PACT AV Access study (Medtronic)—which were presented for the first time during at the 2022 Charing Cross (CX) International...
Treating the dysfunctional vascular access: The expert’s low-pressure, low-dose approach
NOTE: This advertorial is ONLY available in selected countries and geographies
This advertorial, sponsored by BD, is intended for readers in the EMEA region...
More mixed results for DCBs in AV access maintenance as evidence mounts
Additional randomised controlled data regarding the effectiveness of drug-coated balloons (DCBs) in maintaining arteriovenous (AV) access offers new evidence, but it is freighted with...
New tools for CLTI: ISET audience hear what’s on the horizon for these challenging...
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider (University of California San Francisco, San Francisco,...
New tools for CLTI: ISET audience hear what’s on the horizon for these challenging...
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider (University of California San Francisco, San Francisco,...
CX audience supports call to change agency recommendations regarding paclitaxel use in peripheral interventions
Addressing representatives from the US Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA) directly, Thomas Zeller (Bad Krozingen,...
CX audience supports call to change agency recommendations regarding paclitaxel use in peripheral interventions
Addressing representatives from the US Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA) directly, Thomas Zeller (Bad Krozingen,...
PAVE trial finds “no evidence of a benefit” from paclitaxel-coated balloons in preserving AV...
There is no evidence of a benefit from additional paclitaxel-coated balloon use compared to standard balloon angioplasty alone in the context of preserving arteriovenous...
Paclitaxel situation “crystallising” thanks to new data and teamwork, VIVA audience hears
This year's Vascular Interventional Advances annual meeting (VIVA 2020; 6–8 November, online) opened with a session on controversial hot topics and advanced multidisciplinary approaches...
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...
Straub Medical acquired by BD
Straub Medical has approved a full acquisition by Becton, Dickinson and Company (BD). The acquisition was completed on 20 April 2020. Straub Medical manufactures,...
Independent analysis, with oncology input, re-examines DCB data after paclitaxel mortality signal
Kenneth Ouriel (New York, USA) talks to BLearning Peripheral at LINC 2020 (Leipzig Interventional Course; 28–31 January 2020, Leipzig, Germany) about a recent independent analysis to assess safety...
Analysis of DCB use for treatment of central venous stenosis shows promising safety and...
According to the findings of a European multicentre retrospective analysis, the use of drug-coated balloons (DCBs) for the treatment of symptomatic central venous stenosis...
LINC 2020: BD announces long-term safety data for BTK drug-coated balloon
Today at the 2020 Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany), BD announced that interim findings from the Lutonix below-the-knee (BTK) investigational...
Hotly-contested meta-analysis suggests a higher risk of death or amputation at one year when...
A new meta-analysis, just published in the Journal of Vascular and Interventional Radiology (JVIR), suggests significantly worse amputation-free survival at one year with the...
BD announces publication of drug-coated balloon safety data for femoropopliteal PAD
BD has announced the publication of a company-initiated, independent analysis of the Lutonix 035 drug-coated balloon (DCB) femoropopliteal clinical programme in the Journal of...
Interim results of a multicentre analysis support paclitaxel-coated balloon angioplasty
The interim results of a multicentre, European retrospective analysis investigating the use of drug-coated balloons (DCBs) in symptomatic central venous stenosis (CVS) suggest that...
Medtronic and BD respond to FDA circulatory system devices panel
Both Medtronic and BD have released statements in response to the FDA circulatory system devices panel held last week (19–20 June, Washington, DC, USA)....
US FDA panel reviews paclitaxel device data: No recommendations issued, as more work is...
The US Food and Drug Administration (FDA) convened this week for a General Issues Panel Meeting on the late mortality safety signal associated with...
BD receives FDA approval for expansion to drug-coated balloon product line
The US Food and Drug Administration (FDA) has approved expanded sizes of the Lutonix 018 drug-coated balloon (DCB) to treat long superficial femoral artery...
Endovascular options gain ground in creation of haemodialysis lifelines
Until recently, creation, maintenance and restoration of vascular access function was entirely performed by open surgical methods. However, it is becoming apparent that endovascular...
The impact of paclitaxel concerns on vascular access
At the 2019 Charing Cross Symposium (CX; 15–18 April, London, UK), there was a section of the programme on drug-coated balloon trial updates which...
Vascular Leaders Forum discussions seek consensus on paclitaxel
The Vascular Leaders Forum (VLF, 1–2 March, Washington DC, USA), hosted by the non-profit organisation VIVA Physicians, is a special consortium which was called...
How does the novel Temporary Spur device work to “guarantee” drug delivery to vessel...
Jihad Mustapha (Grand Rapids, USA) explains how the Temporary Spur stent system (Reflow), which is a spiked self-expanding stent is intended for use in...
Atherectomy included in pivotal study of QT Vascular’s Chocolate Touch DCB
The FDA has granted approval to include the use of atherectomy for lesion preparation in its ongoing US pivotal study of the Chocolate Touch...
SCAI supports continued use of paclitaxel-coated balloons
Experts from the Society for Cardiovascular Angiography and Interventions (SCAI) have reviewed the recent meta-analysis by Katsanos and colleagues and have concluded that the...
TOBA II BTK clinical trial completes enrolment
The Tack Optimised Balloon Angioplasty II below-the-knee (TOBA II BTK) clinical trial has successfully completed enrolment, ahead of schedule. This study, sponsored by Intact...
Meta-analysis finds a higher risk of death in the long term when paclitaxel-coated devices...
New data, just published in the Journal of the American Heart Association (JAHA), suggest that there is an increased risk of death at two...
Detailing a niche group of patients who do very well with arch branched aortic...
Stéphan Haulon (Université Paris Sud, France) tells Vascular News at Aortic Live 2018 in Essen, Germany, about a niche group of patients, i.e., those that have had...
TOBA II shows repairing dissections after angioplasty “clearly augments” outcomes for PAD patients
Thomas Zeller (Bad Krozingen, Germany) delves into data and design of the TOBA II (Tack Optimized Balloon Angioplasty II) trial with principal investigator William...
Addressing the data deficit for drug-coated balloon use in dialysis access
The first 24-month data from the LUTONIX AV investigational device exemption trial were presented at Charing Cross yesterday. These interim data show a sustained...
Tack Endovascular System secures US$20 million in premarket approval funding
Intact Vascular, a developer of medical devices for minimally invasive peripheral vascular procedures, has announced that it closed a Series C financing totaling US$20 million....
“Promising” 12-month outcomes achieved with the Chocolate Touch drug-coated balloon
The final results of the ENDURE study, investigating the efficacy of the Chocolate Touch drug-coated balloon (QT Vascular), show “promising evidence of the drug...
Particulate embolisation after femoral artery treatment with drug-coated balloons
Drug-eluting technologies, such as balloons coated with paclitaxel (DCB), are now the gold standard treatment for patients presenting with symptomatic peripheral artery disease (PAD) in the...
Enrolment begins in US pivotal study of Chocolate Touch
QT Vascular has started enrolment in its US pivotal clinical study. The study will evaluate the company's Chocolate Touch drug-coated balloon (DCB), for use in...
CX audience homes in on grey area between drug-coated balloons and stents
At the 2017 Charing Cross Symposium (CX; 25–28 April, London, UK), delegates heard brand new data for drug-coated balloons (DCBs) in “wider use” scenarios...
Intact Vascular completes enrolment in TOBA II clinical trial
Intact Vascular’s TOBA II (Tack optimized balloon angioplasty II) clinical trial has completed enrolment. A total of 210 patients have been enrolled in TOBA II at 33 sites...
Global cohorts report drug-coated balloon success above the knee and “promising” results below the...
Three global registries reported fresh data at the 2017 Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany), all of which showed encouraging outcomes for...
TOBA II BTK clinical trial commences enrolment with first implant of Tack Endovascular System
Intact Vascular’s TOBA II BTK (Tack optimised balloon angioplasty II below the knee) clinical trial has commenced enrolment, with the first patient treated by Joseph Cardenas at Yuma Regional Hospital and...
US FDA grants QT Vascular full IDE approval for pivotal trial of Chocolate Touch
The US Food and Drug Administration (FDA) has granted QT Vascular full Investigational Device Exemption (IDE) approval to begin enrolling patients in the pivotal...
QT Vascular announces FDA approval to initiate pivotal trial of Chocolate Touch drug-coated balloon
The US Food and Drug Administration (FDA) has granted QT Vascular conditional Investigational Device Exemption (IDE) approval, allowing the company to begin enrolling patients...
Plain balloon angioplasty remains a useful adjunct to drug-coated balloons for SFA disease
Despite improved outcomes in recent drug-coated balloon trials, standard balloons still have an important and complementary role to play in treating superficial femoral artery...
Enrolment commences for Intact Vascular’s TOBA III trial
Intact Vascular has announced that its Tack Optimised Balloon Angioplasty III (TOBA III) clinical trial has commenced enrolment, with the first patient treated by...
QT Vascular submits request for IDE permission to begin US pivotal trial of its...
QT Vascular has submitted an investigational device exemption (IDE) for permission to begin the pivotal study of the Chocolate Touch drug-coated balloon in the...
CMS approves removal of offset charge associated with pass-through payment for DCBs in the...
With the offset charge removal, the full cost of peripheral drug-coated balloons will be reimbursed under the Medicare outpatient prospective payment system.
BEST-CLI to shed light on top practices for critical limb ischaemia
In September 2014, the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) trial started enrolling patients in North America....
IN.PACT Admiral drug-eluting balloon receives FDA approval
In the IN.PACT SFA trial, the device demonstrated the lowest clinically-driven target lesion revascularisation rate (2.4%) ever reported for an interventional treatment of peripheral arterial disease in the superficial femoral artery.
Vascular News Issue 64 – November 2014 – US Edition
Highlights:
-C-arm angulation increases radiation exposure to operators during complex EVAR
-EXCITE ISR results show superiority of laser atherectomy over angioplasty alone
-Lutonix becomes first drug-eluting balloon...
Vascular News Issue 64 – November 2014
Highlights:
-C-arm angulation increases radiation exposure to operators during complex EVAR
-EXCITE ISR results show superiority of laser atherectomy over angioplasty alone
-Lutonix becomes first drug-eluting balloon...
Not all drug-eluting balloons are equal
By Thomas Zeller
Following successful first-in-man trials (THUNDER, FEMPAC) using the Paccocath/Cotavance coating technology (Bayer, iopromide & 3µg/m2 paclitaxel), two recently presented major pivotal trials...
First drug-eluting balloon approved in USA
The FDA has approved the Lutonix drug-eluting balloon for the management of peripheral artery disease. This is the first time that the agency has approved such a device for this indication in the USA.
LEVANT 2 one-year results presented at FDA panel meeting
Data from the LEVANT 2 trial comparing the Lutonix drug-eluting balloon with angioplasty alone in the treatment of peripheral arterial disease show that the primary endpoints of both safety and efficacy were met and superior efficacy and non-inferior safety of Lutonix compared to control angioplasty was demonstrated.
UH Case Medical Center enrols first patient in LEVANT 2 trial
LEVANT 2 will investigate whether the Moxy drug-coated balloon (Lutonix) is more effective than standard angioplasty at keeping leg arteries open and free from re-blockage over time.
Drug-coated balloons continue to show early promise
Preliminary data for the Lutonix Moxy drug-coated balloon were presented at the Transcatheter Cardiovascular Therapeutics 2010 congress.
Drug-eluting balloons show early promise
Experts say that while drug-eluting balloon technology is showing promising signs, it is too early to claim that this is the next big landmark in endovascular therapy.
