Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented … [Read more...] about FDA approves Boston Scientific’s Agent drug coated balloon
Balloons
FDA approves Gore low-profile balloon-expandable endoprosthesis
W.L. Gore & Associates announced today that it received FDA approval for a lower-profile Viabahn VBX balloon-expandable endoprosthesis. FDA approval builds on the company's proven VBX stent graft for treating complex vascular disease. The company says it offers the longest balloon-expandable stent on the market (79 mm) and the widest range … [Read more...] about FDA approves Gore low-profile balloon-expandable endoprosthesis
Abbott bets on balloons in pulse field ablation battle
One component stands out as unique when you compare the Abbott Volt against competing pulse field ablation (PFA) systems from Medtronic and Boston Scientific. The Volt cardiac ablation catheter has a balloon, something you won’t see on Medtronic’s PulseSelect PFA catheter — the first of its kind approved by the FDA — or the Farawave catheter in … [Read more...] about Abbott bets on balloons in pulse field ablation battle
FastWave Medical kicks off first-in-human study of its IVL tech
FastWave Medical announced the successful completion of enrollment for its first-in-human study of its peripheral intravascular lithotripsy (IVL) system to treat calcified cardiovascular disease. Dr. Miguel Montero-Baker of Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah of HonorHealth Vascular … [Read more...] about FastWave Medical kicks off first-in-human study of its IVL tech
HR Pharmaceuticals licenses dual-balloon catheter tech from Poiesis Medical
HR Pharmaceuticals announced that it entered into an exclusive commercial agreement with Poiesis Medical to license catheter technology. The deal centers around Poiesis' dual-balloon catheter, the Duette system. Under the terms, HR Pharmaceuticals has exclusive commercialization rights to Duette in North America. The deal expands HR … [Read more...] about HR Pharmaceuticals licenses dual-balloon catheter tech from Poiesis Medical
J&J’s Acclarent wins FDA nod for pediatric ear tube balloon dilation system
Johnson & Johnson MedTech unit Acclarent announced that it won a new FDA clearance for its Aera Eustachian tube balloon dilation system. While Acclarent still belongs to Johnson & Johnson, Integra Lifesciences is set to buy it for $275 million next year. While the completion of that deal awaits, the company cleared a regulatory hurdle … [Read more...] about J&J’s Acclarent wins FDA nod for pediatric ear tube balloon dilation system
The 10 most-read catheter-based innovation stories of 2023
This year was a year of firsts for catheter-based innovations, most notably for renal denervation and pulsed field ablation. ReCor Medical won an FDA panel nod for its renal denervation system in August. The panel voted in favor of the safety and efficacy of its Paradise ultrasound renal denervation (RDN) system for treating hypertension. The … [Read more...] about The 10 most-read catheter-based innovation stories of 2023
Surmodics has positive data on multiple drug-coated balloons
Surmodics (Nasdaq:SRDX) today announced positive study results for two of its drug-coated balloon (DCB) technologies. The company presented data supporting the SurVeil and Sundance DCBs at the 50th Annual VEITH Symposium in New York. In the TRANSCEND trial, Surmodics evaluated the safety and efficacy of SurVeil versus the Medtronic In.Pact … [Read more...] about Surmodics has positive data on multiple drug-coated balloons
Surmodics launches new medical device coating technology
Surmodics (Nasdaq:SRDX) announced today that it launched its most advanced hydrophilic medical device coating technology. Eden Prairie, Minnesota-based Surmodics designed the Preside coatings to complement its existing Serene hydrophilic coatings. Preside offers a unique, low-friction and low-particulate generation coating. It further enhances … [Read more...] about Surmodics launches new medical device coating technology
Laborie acquires drug-coated balloon maker Urotronic
Laborie Medical Technologies announced today that it completed the acquisition of drug-coated balloon developer Urotronic. The companies struck an agreement last month for Laborie to buy Urotronic for up to $600 million. Urotronic developed the Optilume DCB used in interventional urology procedures. It treats urethral strictures and benign … [Read more...] about Laborie acquires drug-coated balloon maker Urotronic
