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
Balloons
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
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
FastWave Medical earns FDA IDE approval for next-gen IVL system
FastWave Medical earned FDA investigational device exemption (IDE) approval for its next-generation intravascular lithotripsy (IVL) technology, the company announced today. The approval clears the company to begin a U.S. pivotal trial of its Artero electric IVL system designed to treat peripheral artery disease. "Reaching IDE approval takes a … [Read more...] about FastWave Medical earns FDA IDE approval for next-gen IVL system
Corvention launches KardiaPSI balloon catheter in US with first cases
Corvention announced today that it completed the first case in the U.S. with its proprietary KardiaPSI balloon catheter. The procedure, performed by Dr. Alan Zajarias in St. Louis, marked the official start of a limited rollout for the balloon catheter. Flagstaff, Arizona-based Corvention won FDA clearance for the device in balloon aortic … [Read more...] about Corvention launches KardiaPSI balloon catheter in US with first cases
Airiver treats first patient in drug-coated balloon study for chronic rhinosinusitis
Airiver Medical today announced the successful treatment of the first patient in a pivotal clinical trial of its drug-coated balloon (DCB). The first patient received treatment for chronic rhinosinusitis (CRS) in its RESTORE-2 U.S. pivotal clinical trial. It evaluates the Brooklyn Park, Minnesota-based company's Airiver ESSpand sinus DCB. Dr. … [Read more...] about Airiver treats first patient in drug-coated balloon study for chronic rhinosinusitis
Advanced NanoTherapies raises $31M for drug-coated balloon tech
Advanced NanoTherapies announced that it closed an oversubscribed Series B financing worth more than $31 million. An undisclosed strategic investor, along with S3 Ventures, co-led the round. The T45 Fund and new and existing investors also participated. Funding adds to $4 million raised in 2023. The funds support the company's therapies for … [Read more...] about Advanced NanoTherapies raises $31M for drug-coated balloon tech
Olympus to acquire urologic balloon spacer maker BioProtect for $270M
Olympus announced today that it entered into a definitive agreement to acquire urologic medical device manufacturer BioProtect. The deal includes a value of $270 million, with certain amounts held in escrow for a period dependent on uninterrupted business operation. Tokyo-based Olympus expects to complete the deal by the end of the second … [Read more...] about Olympus to acquire urologic balloon spacer maker BioProtect for $270M
