Endospan today announced the presentation of 30-day results from a study evaluating its Nexus aortic arch stent graft system. Results came out of the statistical dissection primary arm from the TRIOMPHE FDA investigational device exemption (IDE) study. Investigators presented findings at the American Association for Thoracic Surgery (AATS) … [Read more...] about Endospan has positive aortic arch stent graft study results
Stents
Data backs Boston Scientific drug-eluting stent
Boston Scientific today shared study data supporting the use of its Eluvia drug-eluting stent for treating PAD. The company shared multiple new clinical data sets at Charing Cross 2025 in London today. Findings reinforced the growing body of evidence supporting the Eluvia stent for treating peripheral artery disease (PAD) — particularly in the … [Read more...] about Data backs Boston Scientific drug-eluting stent
Terumo Neuro wins FDA nod for first dual-layer carotid stent
Terumo Neuro (formerly MicroVention) announced today that it received FDA premarket approval (PMA) for its Carotid Stent System. Aliso Viejo, California-based Terumo Neuro says this marks the first dual-layer micromesh carotid stent approved in the U.S. It offers physicians a clinically proven option to improve patient outcomes in carotid artery … [Read more...] about Terumo Neuro wins FDA nod for first dual-layer carotid stent
Abbott is making an IVL play with FDA IDE nod
Abbott announced today that it received FDA investigational device exemption (IDE) approval for its coronary intravascular lithotripsy (IVL) system. IDE enables the company to evaluate the system in treating severe calcification in coronary arteries prior to stenting. The company expects its TECTONIC coronary artery disease (CAD) IVL trial to … [Read more...] about Abbott is making an IVL play with FDA IDE nod
Second Heart Assist says Whisper device caused less hemolysis compared to Abiomed Impella CP
Second Heart Assist today announced data from a study highlighting the performance of its Whisper device against a competitive heart pump. The study showed that Whisper — a next-generation percutaneous mechanical circulatory support (pMCS) system — caused significantly less hemolysis than the widely used Johnson & Johnson MedTech/Abiomed … [Read more...] about Second Heart Assist says Whisper device caused less hemolysis compared to Abiomed Impella CP
BD warns on atherectomy catheters after deaths
BD (NYSE: BDX) recently issued a medical device correction later related to its Bard subsidiary's Rotarex atherectomy system. The company identified a number of anatomical factors that could contribute to catheter helix fracture and/or breakage. It reports 30 serious injuries and four deaths associated with the issue. Additionally, BD reported … [Read more...] about BD warns on atherectomy catheters after deaths
Aptyx acquires Medical Murray facility in North Carolina
NEWS RELEASE: Aptyx amplifies its expertise in complex interventional products with the acquisition of Medical Murray's North Carolina facility Tempe, Arizona – Aptyx, a leading global developer and manufacturer of complex components and devices for the life sciences, today announced the acquisition of the Charlotte, North Carolina facility of … [Read more...] about Aptyx acquires Medical Murray facility in North Carolina
Medtronic inks stent distro deal with Contego with option to buy
Medtronic (NYSE: MDT)announced today that it entered into an exclusive U.S. distribution agreement with Contego Medical. Under the agreement, Medtronic serves as the sole U.S. distributor for Contego's portfolio of commercially available products. Raleigh, North Carolina-based Contego offers products that provide revascularization treatment for … [Read more...] about Medtronic inks stent distro deal with Contego with option to buy
Endologix picks former Medtronic executive as new CEO
Endologix announced today that President and CEO Dr. Matt Thompson intends to step down and take on a new role. Thompson plans to transition into the position of EVP and chief medical officer. As a result, the company appointed Dr. John Liddicoat as its new president and CEO, effective immediately. Richard Mott, Endologix's board chair, said … [Read more...] about Endologix picks former Medtronic executive as new CEO
FDA approves Merit Medical’s cell-impermeable endoprosthesis
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA premarket approval for its Wrapsody cell-impermeable endoprosthesis. With approval, the company can begin commercializing the device in the U.S. in 2025. South Jordan, Utah–based Merit Medical designed Wrapsody to extend long-term vessel patency in dialysis patients. It … [Read more...] about FDA approves Merit Medical’s cell-impermeable endoprosthesis
