Vascular News

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Life Seal Vascular recently announced that it has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant. The funding will be used to accelerate the development of the company’s #EVAR technology. Vascular surgeon Michel Reijnen (Rijnstate Hospital, Arnhem, The Netherlands) commented on the significance of Life Seal Vascular’s technology, stating: “The advancements being made by Life Seal Vascular are truly remarkable. Their innovative solutions have the potential to revolutionise EVAR, offering patients safer and more effective treatment options. I am excited to see the positive impact this technology will have on the field and on patient care.” Read more: https://lnkd.in/eieHZQdg

Luminor anticipated to have a “big impact” on the Japanese market following SOL-Japan results Yoshimitsu Soga (Fukuoka, Japan) spoke to Vascular News at the Leipzig Interventional Course (LINC) 2024 (28–31 May, Leipzig, Germany) about the SOL-Japan trial. Continue reading: https://lnkd.in/eF78SUwD This video is sponsored by iVascular #Luminor #DCBtrials

Matteo Tozzi (Varese, Italy) and Steiner Kate (Stevenage, UK) sat down with Vascular News at this year’s Charing Cross (CX) International Symposium (23–25 April, London, UK) to provide their thoughts on the latest findings from the IN.PACT AV Access randomised controlled trial (RCT) evaluating the IN.PACT AV drug-coated balloon (DCB; Medtronic) in dialysis patients with dysfunctional arteriovenous fistulas (AVFs). In light of five-year IN.PACT AV Access data—presented at CX 2024 by Andrew Holden (Auckland, New Zealand)—Tozzi points to the durability that these results demonstrate, as well as the positive cost effectiveness and reduced retreatment rate the IN.PACT AV DCB appears to enable compared to standard percutaneous transluminal angioplasty (PTA). “In my clinical practice DCB is the first treatment for the stenosis in vascular access”, he comments, by noting that for patients on haemodialysis, “survival time is really linked to good functionality of the access circuit”, offering advice on optimal practices to his peers: “Please use DCB, […] because it’s the key point for maintaining the lives of these patients for the longest time possible.” Steiner adds to these points, commenting that positive, long-term data from IN.PACT AV Access have now allayed any lingering mortality-related concerns regarding paclitaxel—“we can now use [DCBs] knowing that they are safe, in terms of mortality signals, in AV access”. She goes on to note that, within the algorithm for treating patients with dysfunctional dialysis accesses, there is “definitely a place” for DCB use. “If I wanted to persuade someone who was opposed to DCB use, I’d say, ‘come and talk to some of our patients’. […] We do have a few patients who are great advocates for the technology,” Steiner concludes. This video is sponsored by Medtronic. Watch the full video here: https://lnkd.in/dWAfV4H4 #dcb #AVaccess #endoAVF #maintenance #ESKD #dialysis #vascularaccess #endovascular

The top 10 most-read Vascular News stories in June featured two US FDA investigational device exemption (IDE) approvals and a series of highlights from this year’s Vascular Annual Meeting (VAM 2024; 19–22 June, Chicago, USA). Read more: https://lnkd.in/dmMiKcPR

Humacyte’s Acellular Tissue Engineered Vessel, a bioengineered regenerative vessel, is currently in clinical trial phases as a universally implantable vascular conduit that is non-immunogenic and that resists infection after implantation. Designed to be ready off-the-shelf, the ATEV has the potential to save valuable time for surgeons who treat injured patients, and to improve outcomes and reduce complications. The ATEV has accumulated more than 1,200 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease. The US Food and Drug Administration (FDA) accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA) seeking approval of the ATEV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The FDA’s BLA decision is targeted for August 10, 2024. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Watch the video here: https://lnkd.in/dUseJchf For more information, visit www.Humacyte.com. ™ Indicates a trademark of Humacyte Global, Inc. © 2024 Humacyte Global, Inc. All Rights Reserved This video was filmed by Humacyte and is being sponsored for distribution in association with Vascular News and CX Vascular. Biba Medical bears no responsibility for the assets used in the production of this video. #ATEV #AcellularTissueEngineeredVessel #Humacyte #ArterialRepair

Avicenna.AI has received Medical Device Regulation (MDR) certification for five of its algorithms from British Standards Institution (BSI) Medical Devices—a development that means the company’s product portfolio is fully compliant with the European Union’s (EU) MDR 2017/745, which is now mandatory for medical device companies wanting to provide solutions in Europe. Read more: https://lnkd.in/dxagkaYs

New data presented at the 2024 Vascular Annual Meeting (VAM; 19–22 June, Chicago, USA) have revealed poor overall rates of medical therapy adherence in moderate asymptomatic #carotid stenosis patients—with smoking cessation representing a “ripe target” for improvement moving forward. Read more: https://lnkd.in/ecNi9hTW

Humacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA for its investigational acellular tissue engineered vessel (ATEV), designed to treat patients with advanced peripheral arterial disease (PAD). This RMAT designation was granted at the same time as the FDA cleared a new Investigational New Drug (IND) application for the PAD indication for ATEV, formerly referred to as the human acellular vessel (HAV). Read more: https://lnkd.in/e3aSRmjS

Artivion, Inc. recently announced it has amended its credit facility and option purchase agreements with Endospan Ltd., developer of the Nexus stent graft system. Read more: https://lnkd.in/eJ2C5YrH