The Teleflex (NYSE: TFX) Freesolve RMS (resorbable magnesium scaffold) has won FDA Breakthrough Device designation for percutaneous coronary intervention (PCI). "Freesolve RMS has the potential to provide physicians with an additional treatment option, by reducing the need for permanent implants and potentially offering an alternative to … [Read more...] about Teleflex wins Breakthrough Device designation for Freesolve resorbable scaffold
Regulatory
J&J launches faster Shockwave coronary catheter in the US
Johnson & Johnson (NYSE: JNJ) is launching the latest version of its intravascular lithotripsy catheter for cracking calcium within the coronary arteries, which the company said it designed to cut treatment times in half. The Shockwave C2 Aero Fly catheter delivers ultrasonic energy at double the speed of its previous version and with less … [Read more...] about J&J launches faster Shockwave coronary catheter in the US
Haemonetics wins FDA approval of PerQseal Elite vascular closure system
Haemonetics (NYSE: HAE) has received FDA approval for its PerQseal Elite vascular closure system for large-bore arterial procedures, following the company's $116.4 million acquisition of Vivasure Medical in January 2026. The FDA approval, announced yesterday, expands Boston-based Haemonetics' U.S. portfolio of large-bore closure devices for … [Read more...] about Haemonetics wins FDA approval of PerQseal Elite vascular closure system
E2’s pulmonary embolism platform claims two FDA clearances
Endovascular Engineering (E2) has received a pair of FDA clearances for its pulmonary embolism treatment platform, spanning its dual-action thrombectomy system and hardware that returns filtered blood to the patient. The Hēlo system combines continuous vacuum aspiration with physical agitation to help break up the blood clot. Its catheter starts … [Read more...] about E2’s pulmonary embolism platform claims two FDA clearances
FDA approves Gore bridging stent graft in complex aortic aneurysms
W. L. Gore & Associates received expanded FDA approval, broadening the use of its balloon-expandable stent graft, opening it up for the treatment of complex aortic aneurysms. The Viabahn VBX endoprosthesis was greenlit for use in both fenestrated and branched endovascular aortic repairs, known as FEVAR and BEVAR, where an aneurysm develops … [Read more...] about FDA approves Gore bridging stent graft in complex aortic aneurysms
Cordis earns FDA nod for Selution SLR drug-eluting balloon
Cordis earned FDA approval for its Selution SLR (sustained limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis, the device developer announced today. “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary … [Read more...] about Cordis earns FDA nod for Selution SLR drug-eluting balloon
XCath Robotics receives FDA breakthrough nod for Iris system
XCath Robotics has FDA Breakthrough Device Designation for its in-development Iris surgical robotic system for mechanical thrombectomy to treat acute ischemic stroke. Houston-based XCath says the designation provides increased opportunities to interact with FDA experts and receive support during the regulatory development and review process for … [Read more...] about XCath Robotics receives FDA breakthrough nod for Iris system
Abbott earns FDA approval for new dual-energy ablation catheter
Abbott (NYSE: ABT) earned FDA approval for its new dual-energy catheter, TactiFlex Duo sensor-enabled ablation catheter. TactiFlex Duo joins Johnson & Johnson MedTech’s ThermoCool SmartTouch SF and Medtronic's Affera Sphere-9 catheter in the U.S. dual-energy ablation catheter market. Medtronic won its Sphere-9 approval in 2024, and J&J … [Read more...] about Abbott earns FDA approval for new dual-energy ablation catheter
Medtronic says Endurant stent graft’s new CE mark could boost use for ruptured AAA
![The Endurant stent graft system. [Image courtesy of Medtronic]](https://www.medicaltubingandextrusion.com/wp-content/uploads/2025/10/Endurant_Hero_woDS-1-300x195.jpg)
Medtronic (NYSE: MDT) has secured a CE mark for its Endurant stent graft, removing a treatment warning related to its use in ruptured abdominal aortic aneurysms (AAA). The Minnesota-run medtech giant received a similar FDA labeling change in late 2025. A ruptured AAA occurs when the main artery in the abdomen bursts, causing severe internal … [Read more...] about Medtronic says Endurant stent graft’s new CE mark could boost use for ruptured AAA
Boston Scientific discontinues Imager II angiographic catheter sales
Boston Scientific recalled and discontinued all Imager II angiographic catheters due to a manufacturing issue, according to an FDA early alert. Imager II angiographic catheters are diagnostic intravascular catheters used to capture images of the patient’s peripheral vasculature. Boston Scientific determined the catheters were “manufactured … [Read more...] about Boston Scientific discontinues Imager II angiographic catheter sales
