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...
A new application of Cellectra electroporation technology (Inovio) could dramatically enhance the ability of DNA therapy to stimulate blood vessel growth and recovery from debilitation caused by peripheral arterial disease and critical limb ischaemia.
Results from the MIMICS study have shown a 12-month Kaplan Meier estimate of freedom from clinically driven target lesion revascularisation of 91.2% for patients treated with the new BioMimics 3D stent.
The authors of the Italian registry stated that a stent-less therapy approach with a drug-eluting balloon and optimal angioplasty provides favourable outcomes and is likely to leave more interventional options open for the future.
"As the largest below-the-knee critical limb ischaemia randomised trial, and the first and only drug-eluting balloon multicentre randomised trial of any kind, IN.PACT DEEP has the potential to shift the treatment paradigm for this challenging patient population," said Iris Baumgartner, one of the principal investigators of the trial.
Endovascular treatment for arterial recanalisation in diabetic patients with critical limb ischaemia and foot lesions is currently accepted and indicated as the first choice treatment, Marco Manzi told delegates at the VEITHsymposium in New York, USA.
In a late-breaking trial session at LINC 2021 (The Leipzig Interventional Course, 25–29 January, online), key updates on below-the-knee (BTK) interventions were in the spotlight. Speaking during his...
According to Jotec, the E-vita abdominal XT device offers a new designed multifunctional wire-reinforced catheter with high flexibility in the proximal part and outstanding pushability in the distal portion without any risk of kinking.
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...
VasQ, a high haemocompatibility biosynthetic vascular device from Laminate Medical Technologies, could be protective against the haemodynamic modifications that occur during arteriovenous fistulae (AVF)...
A vessel preparation treatment strategy of directional atherectomy prior to drug-coated balloon angioplasty with Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) in long, calcified femoropoliteal...
In a series of Podium 1st presentations from world-class faculty, CX 2020 LIVE attendees heard the latest data on peripheral arterial disease management and an evaluation of different types of stents, including...
Intact Vascular has announced the peer-reviewed publication of its Tack optimised balloon angioplasty (TOBA) III 12-month clinical trial results in the Journal of Vascular Surgery.
The multi-centre, single-arm,...
Endovascular arteriovenous fistulas (endoAVF) platforms add additional fistula options for patients and physicians, argues Dheeraj Rajan (University Health Network, University of Toronto, Toronto, Canada,...
Vivasure Medical has announced the European launch of the PerQseal closure device for large-bore transcatheter procedures, including transcatheter aortic valve implantation (TAVI), thoracic endovascular...
NuCryo Vascular has signed a commercialisation agreement with Lokai Medical, a specialty distributor of coronary/peripheral and interventional devices, to distribute the PolarCath balloon dilatation...
Positive single-centre 24-month results from Intact Vascular’s TOBA (Tack optimised balloon angioplasty) clinical study were presented at the 2017 VEITHsymposium 2017 (14–18 November, New York City, USA) by...
The US Food and Drug Administration (FDA) has granted Humacyte’s Humacyl investigational human acellular vessel (HAV) Regenerative Medicine Advanced Therapy (RMAT) designation.
This designation means...
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...
Despite significant advances in pharmacotherapy and device technology for percutaneous cardiovascular interventions, the fundamental technique of manually advancing intravascular devices at the patient’s table...
The decision will provide patients with additional access to the IN.PACT Admiral drug-coated balloon with the potential to improve the standard of care for peripheral arterial disease in vessels above the knee.
The company's Cathi hybrid catheter is to be used in a safety and efficacy peripheral atherectomy study planned for Q4 2015. According to Eximo, the technology has the potential to optimise safety and performance expected to reduce the risk of vessel perforation.
Initial patients in the study were enrolled in Rotterdam, the Netherlands, and Milan, Italy, where Manta 18F devices were successfully deployed achieving immediate haemostasis following transcatheter aortic valve replacement.
At SITE, Gustavo S Oderich said that there are no definitive studies supporting routine use of embolic protection devices in superficial femoral artery interventions. However, he stated that these devices prevent embolisation during complex procedures.
According to the company, the ViperWire advance peripheral guidewire with flex tip offers greater flexibility and navigation; improves systems' ease-of-use when treating calcified lesions in torturous arterial anatomy.
Presented for the first time at EuroPCR 2015, new clinical data from two different studies show that the IN.PACT Admiral drug-coated balloon successfully treated long lesions in the superficial femoral and popliteal arteries.
Medtronic's EverFlex is a nitinol stent system that expands to a predetermined diameter to re-open stenotic regions of the superficial femoral artery and proximal popliteal arteries that supply blood to the legs.
The PolarCath peripheral dilatation system is indicated for use in dilating stenoses in the peripheral vasculature and for the treatment of obstructive lesions of PTFE access grafts or arteriovenous dialysis fistulae.
A study published in the European Journal of Vascular and Endovascular Surgery shows that in the carotid arteries, stent malapposition is more frequent with closed-cell stents while plaque prolapse is more common with open-cell stents.
The results of the BAROSLEEP study, published in EJVES, show that microstructural white matter damage is associated with poor outcome in patients with claudication requiring surgical revascularisation. Timo Laitio spoke to Vascular News about the study and its clinical implications.
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.
QT Vascular has announced that it has enrolled the first European patients in the ENDURE trial in Germany. Multiple patients have already been enrolled in this study by Andrew Holden, Auckland, New Zealand.
Andre Bouhasin, an interventional cardiologist with West County Heart and Vascular Diagnostics, St Louis, Missouri, USA, used a novel device to remove blood clots and emboli from a protective filter and native arteries to restore blood flow in a patient's leg.
The multicentre, 800-patient study also demonstrated that directional atherectomy was non-inferior for treating peripheral arterial disease in patients with diabetes compared with those without diabetes.
Results from a feasibility study conducted in Italy indicate that ultrasound-enhanced paclitaxel delivery inhibits arterial smooth muscle proliferation after balloon angioplasty in peripheral arterial disease.
Covidien's Stellarex drug-coated angioplasty balloon continues to be shown as safe and effective for treatment of peripheral arterial disease, according to new 24-month data released from the company's ILLUMENATE first-in-human study.
TriReme Medical announced that the first three patients were enrolled in a clinical study of its unique drug-coated Chocolate percutaneous transluminal angioplasty balloon. Andrew Holden, co-principal investigator of the study, performed these procedures at Auckland City Hospital, in Auckland, New Zealand.
In a study presented at the AHA Scientific Sessions and published online in JAMA, researchers have found that therapy with granulocyte-macrophage colony stimulating factor (GM-CSF) did not improve treadmill walking time at three months of follow-up.
Data presented at a late breaking clinical trials session at VIVA13 show that the 3D helical geometry of the BioMimics stent has demonstrated safety and promising clinical performance at 12 months in patients with femoropopliteal lesions.
Patrice Bergeron, Marseille, France, presented initial results of a new device used in the treatment of peripheral arterial disease at the MEET Congress. The new balloon deploys a microneedle into the adventitia and diffuses anti-inflammatory drug into the arterial wall.
The Pantheris system combines directional atherectomy capabilities with real-time intravascular visualisation to remove plaque from blocked arteries. The system is designed to remove the blockage while avoiding the disruption of normal arterial wall structures.
The acquisition expands Abbott's global peripheral technology portfolio with IDEV Technologies' Supera Veritas self-expanding nitinol stent system, which has the CE mark for treating peripheral arterial disease.
The ongoing global clinical programme of In.pact drug-eluting balloons for the treatment of peripheral artery disease in the lower extremities includes 24 studies involving more than 4,200 patients at approximately 230 sites worldwide.
Thomas Zeller, Bad Krozingen, Germany, and colleagues, reported their initial experience with the Proteus embolic capture angioplasty balloon for peripheral vascular disease in 15 patients in the Journal of Endovascular Therapy.
At the LINC congress, Dierk Scheinert presented the details of a randomised trial that will evaluate the Zilver PTX drug-eluting stent vs. paclitaxel-eluting balloons in symptomatic femoropopliteal artery disease.
Results from a phase II study in patients who underwent percutaneous revascularisation of the superficial femoral artery and received the IL-1a True Human monoclonal antibody (MABp1, XBiotech) have shown a 58% reduction in major adverse cardiovascular events and 60% longer patency in treated vessels compared to control patients.
The new configuration of this vascular graft used for replacement or bypass of diseased vessels, allows physicians to access even deeper vessels and create new access sites in anatomical locations that would have otherwise been abandoned.
"In the SUPERB trial, the Supera stent achieved one-year patency rates not previously achieved in a pivotal trial for any stent placed in the superficial femoral artery (SFA) and proximal popliteal artery," said Kenneth Rosenfield, co-principal investigator of the trial at VIVA 2012.
Vascular News has learned from industry sources at the CIRSE annual meeting that Bayer HealthCare is looking into discontinuing the production of the Cotavance drug-eluting balloon using the Paccocath technology.
By Anna Maria Ierardi and Gianpaolo Carrafielo
Endovascular treatment for atherosclerotic obstructions in femoropopliteal arteries is widely used for patients with intermittent claudication and critical...
The preliminary results of the study show that a paclitaxel-eluting balloon seems to provide better results in terms of 12-month restenosis and re-occlusion below the knee compared to conventional balloon angioplasty.
Children with acute limb ischaemia should be treated conservatively with observation and anticoagulation, and intervention should be performed only in cases presenting tissue loss, a study presented by Jesus M Matos at the Society for Vascular Surgery Annual Meeting has recommended.
For angiogenic gene therapy, mixed results in phase I/II trials were followed by a negative result in a very large phase III trial (TAMARIS), Sigrid Nikol, Asklepios Klinik St Georg, Hamburg, Germany, will tell delegates at CX 33.
Although earlier trials were promising, the TAMARIS trial showed that an experimental gene therapy growth factor failed to prevent death or amputations in patients with severely blocked lower limb blood vessels. Sigrid Nikol, Asklepios Klinik St Georg, Hamburg, Germany, explains to VascularNews.com the negative results of TAMARIS.
A range of new products for the treatment of vascular disease will be launched and showcased at the CX Symposium. Aorfix (Lombard), Lifestent (Bard), Viabahn (Gore), IN.PACT (Invatec), and VenaCure EVLT (Angiodynamics) are some of the innovations available in the industry area.