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) Annual Meeting in Seattle. TRIOMPHE evaluates the […]
Stents
Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA investigational device exemption (IDE) for its Virtue drug-coated balloon. It marks the second major regulatory milestone for Orchestra BioMed in just a week. The company last week picked up FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) therapy. FDA IDE enables the company to […]
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 superficial femoral […]
R3 Vascular reports first patient treated in next-gen drug-eluting scaffold study
R3 Vascular announced today that a doctor treated the first patient in the ELITE-BTK pivotal trial of its drug-eluting bioresorbable scaffold. Dr. Brian DeRubertis of New York-Presbyterian and Weill Cornell Medicine treated the first patient. The trial evaluates the company’s next-generation Magnitude drug-eluting bioresorbable scaffold for below-the-knee peripheral arterial disease (PAD). Mountain View, California-based R3 […]
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 disease treatment. The stent system […]
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 enroll up to 335 subjects at […]
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 Impella CP when both pumps were operated […]
Reflow Medical expands global reach with European subsidiary
Reflow Medical announced today that it opened a European subsidiary in Landsberg am Lech, Germany, to expand outside the U.S. The company said its strategic expansion strengthens its international presence and enhances its ability to serve markets globally. SVP and GM Knut Saurteig leads the subsidiary, called Reflow Medical Europe GmbH. Under his leadership, the […]
Philips discontinues Tack endovascular system sales after serious recall
The FDA has deemed a recall of the Philips Tack endovascular system Class I, the most serious kind. This recall involves removing devices from use and sale. According to the FDA notice, the device may cause serious injury of death if customers continue to use it. As a result of the recall, Philips plans to […]
Biotronik shifts strategy to focus on implantable devices
Biotronik today announced a strategic shift that includes the divestiture of its Vascular Intervention (VI) business to Teleflex. This deal comes as part of a major change at Teleflex, too, as the company today announced plans to separate into two separate businesses. Biotronik said its shift aims to strengthen its leadership in active implantable devices […]
BD warns on atherectomy catheters after deaths
BD 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 115 cases requiring additional intervention following helix […]
