FLAGSTAFF, Arizona (July 7, 2026)—W. L. Gore & Associates’ medical business (“Gore”) announced today that the U.S. Food and Drug Administration has approved updated labeling for the GORE® EXCLUDER® AAA Endoprosthesis and the GORE® EXCLUDER® Conformable AAA Endoprosthesis, adding real‑world clinical evidence that supports the use of EVAR devices in appropriately selected patients with ruptured abdominal aortic […]
Peripheral/Endo
Shape Memory Medical Completes Enrollment in Landmark AAA‑SHAPE Randomized Controlled Pivotal Trial
SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of the only commercially available volume‑expanding shape memory polymer for endovascular embolization, announced today that it has completed enrollment in the AAA‑SHAPE Pivotal Trial, a prospective, multicenter, randomized, open‑label controlled study evaluating the safety and effectiveness of the IMPEDE‑FX RapidFill® Device when used alongside endovascular aneurysm repair, or EVAR, to improve abdominal aortic aneurysm (AA
Xeltis makes first commercial implant of aXess™, its vascular access device for hemodialysis
Marks start of European commercial rollout of aXess™, bringing it into routine clinical practiceBuilds on CE mark approval in record time, underpinned by positive EU pivotal trial dataIntroduces a first-of-its-kind living vascular access solution for patients requiring hemodialysis EINDHOVEN, The Netherlands, July 07, 2026 (GLOBE NEWSWIRE) — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announced today the official start of the European commercialization of aXess™, marked by the successful treatment of the first commercial patient by Dr Dominik Liebetrau at Artemed Klinikum Munich South, Germany. aXess™ represents a new category of vascular access. Implanted in a single procedure and based on Nobel Prize-winning supramolecular science, the medical device initially serves as a scaffold ready for cannulation before gradually transforming into each patient’s own living vessel, for long-term, reliable vascular access. The commercial launch follows positive 12-month European pivotal data demonstrating secondary patency comparable to matured arteriovenous fistulas (AVFs), alongside lower reintervention rates and high infection resistance compared with historical arteriovenous graft (AVG) benchmarks. It marks the beginning of Xeltis’ broader European rollout of aXess™, providing more physicians and patients with a differentiated vascular access solution that has the potential to transform the hemodialysis treatment landscape. Dr. Dominik Liebetrau, Head of Vascular Surgery at Artemed Klinikum Munich South, Germany, said: “aXess™ integrated seamlessly into our existing surgical workflow, making adoption straightforward for our team. It offers a fundamentally new approach to vascular access – providing an implant that is designed to transform into the patient’s own living vessel. This provides physicians with a valuable new option for patients requiring long-term hemodialysis access and has the potential to improve treatment outcomes and quality of life.” Eliane Schutte, Chief Executive Officer, Xeltis, added: “The first commercial implantation of aXess™ marks the transition from clinical development into routine patient care. It is an important milestone for Xeltis and the beginning of our European commercial launch, bringing a new treatment option to patients and physicians, while building the foundation for broader adoption across Europe and, ultimately, the U.S.” Elmar Horn, Vice President of Commercial, Xeltis, said: “Our first commercial implant is a significant milestone for Xeltis and reflects the commitment of our team and our physician partners. Our focus now is on supporting participating centers as they adopt aXess™, delivering a positive experience for patients and physicians, and responsibly expanding patient access across Germany and Europe.” Peter A. Schneider, Member of the Medical Advisory Board, Xeltis commented: “This is the first time we have access to a non-autologous conduit designed to become the patient’s own vessel over time through vascular cell in-growth and tissue regeneration, ultimately behaving more like an autologous vessel. This approach has the potential to address a significant unmet need in vascular access by combining fast availability for cannulation with the long-term benefits of a living vessel.” Alongside European commercialization, Xeltis continues enrollment in its US pivotal trial of aXess™, now exceeding 50% enrollment. The study builds on the positive European pivotal data and supports the Company’s broader global commercialization strategy. Contacts XeltisEliane Schutte, CEOAlexander Goemans, CFOinfo@xeltis.com Optimum Strategic CommunicationsNick Bastin, Eleanor Cooper, Aoife Minihan +44 (0) 208 078 4357xeltis@optimumcomms.com About XeltisXeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company’s proprietary Restorex® platform utilizes an advanced polymer implant which transforms to the patient’s own tissue before gradually being absorbed and leaving new, living and long-lasting vessels in place. Xeltis’ most advanced product currently under commercial launch is aXess™, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors. Visit the Xeltis website for more details: https://xeltis.com/
3-Year DETOUR2 Results Demonstrate Sustained Symptom Relief and Limb Preservation in Complex SFA Disease
SANTA ROSA, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company focused on advancing innovative therapies for the interventional treatment of vascular disease, today announced publication of 36-month results from the DETOUR2 clinical trial evaluating Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR™ System in the Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI).The DETOUR2 Trial is a prospective, single-arm, intern
Xeltis exceeds 50% enrollment in US Pivotal trial for aXess™, its vascular access device for hemodialysis
Xeltis announces that it has exceeded 50% enrollment in its US pivotal trial for aXess™
VEMERIX Publishes Industry Report on the Global Shift from Open Vein Surgery to Endovenous Laser Ablation
VEMERIX analysis finds the single-use consumable, not the capital laser console, is the value engine in the USD 1.4–1.6 billion varicose-vein device market — with Asia-Pacific growing fastest at up to 8.4% CAGR. WEIHAI, China, June 29, 2026 /PRNewswire/ — VEMERIX, the international…
Data Presented on Two-Year Proximal Neck Dynamics from First-in-Human Study of Abdominal Aortic Aneurysm Treatment
TEMPE, Ariz., June 25, 2026 (GLOBE NEWSWIRE) — Nectero Therapeutics announced today a first-in-human (FIH) multicenter study evaluated treatment of small- to medium-sized abdominal aortic aneurysms (AAA) with pentagalloylglucose (PGG) using its investigational Nectero EAST® System. The study met safety endpoints, and AAA growth rates were significantly lower than expected through two years post-treatment. At the 2026 Vascular Annual Meeting (VAM) held in Boston last week, the impact of PGG treatment on proximal neck dynamics was presented by Dr. Matthew Eagleton, Chief, Mass General Brigham Vascular and Endovascular Surgery.
Microbot Medical® Announces First Health System in Pennsylvania to Adopt the LIBERTY® Endovascular Robotic System
Microbot Medical® Announces First Health System in Pennsylvania to Adopt the LIBERTY® Endovascular Robotic System
GuideAI Health Receives FDA 510(k) Clearance for VascularAssist Occlusion Triage
AI-Powered Triage Software Helps Radiologists Identify and Prioritize Peripheral Vascular Disease in Lower-Extremity CT Imaging AI-Powered Triage Software Helps Radiologists Identify and Prioritize Peripheral Vascular Disease in Lower-Extremity CT Imaging
Ruixiang Silicone Releases Platinum-Cured Medical Silicone Tubing for Cardiac, Infusion, and Hemodialysis Device Manufacturers
USP Class VI, ISO 10993 biocompatibility evaluation, and ISO 13485:2016 quality system certification, manufactured at an FDA-registered facility DONGGUAN, China, June 16, 2026 /PRNewswire/ — Dongguan Ruixiang Precision Silicone Products Co., Ltd. (Ruixiang Silicone) has released a…



