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
Technologies & Devices
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
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
J&J delivers Shockwave data sustaining below-the-knee gains for two years
Johnson & Johnson MedTech (NYSE: JNJ) shared extended clinical findings from its Shockwave intravascular lithotripsy system, from a study aimed at clearing calcified vessel blockages below the knee in patients with peripheral artery disease. In late-breaking data presented at the Vascular InterVentional Advances 2026 conference in Las Vegas, … [Read more...] about J&J delivers Shockwave data sustaining below-the-knee gains for two years
Medtronic snags breakthrough designation for below-the-knee drug-coated balloon
Medtronic (NYSE:MDT) has secured a breakthrough designation from the FDA for a version of its drug-coated balloon aimed at unblocking arteries below the knee, following years of development. The In.Pact BTK catheter is slated for an international, randomized pivotal trial that plans to enroll about 400 participants with peripheral artery disease … [Read more...] about Medtronic snags breakthrough designation for below-the-knee drug-coated balloon
BD’s IV catheters plant in Utah marks 70 years
BD (NYSE:BDX) is celebrating the 70th birthday of its major manufacturing facility in Utah, which the company said produces billions of molded components each year. Located in the town of Sandy just south of Salt Lake City, the site was founded in 1956 under Deseret Pharmaceuticals. BD acquired the plant in 1986, and today it’s home to a … [Read more...] about BD’s IV catheters plant in Utah marks 70 years
HighLife raises more than $90M to advance its TMVR system
HighLife (Paris) recently announced it raised €80 million (more than $90 million U.S.) for a U.S. pivotal study and expanded European commercialization of its TMVR system. The successfully completed fundraise, announced Sept. 22, was co-led by Andera Partners, Sofinnova Partners, Supernova Invest and Mérieux Equity Partners. Other new investors … [Read more...] about HighLife raises more than $90M to advance its TMVR system
Perfuze’s super-bore stroke catheter tops conventional, cyclic aspiration in bench study
Following FDA clearance earlier this year, Perfuze is putting forward new data comparing its super-bore aspiration catheter to conventional suction methods for removing stroke-causing blood clots, as well as the emerging approach of cyclic aspiration. The three-way benchtop study of the company’s Millipede88 catheter, tested with in vitro models … [Read more...] about Perfuze’s super-bore stroke catheter tops conventional, cyclic aspiration in bench study
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
