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) … [Read more...] about Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
Balloons
Cordis shares positive study results from multiple drug-eluting balloon studies
Cordis announced new data from two major peripheral studies evaluating its Selution SLR drug-eluting balloon. The Miami Lakes, Florida-based company presented 12-month results from the SUCCESS PTA study at the Charing Cross Symposium in London. It then shared SELUTION SFA Japan three-year results today at the Japan Endovascular Treatment … [Read more...] about Cordis shares positive study results from multiple drug-eluting balloon studies
Cagent Vascular initiates balloon angioplasty study
Cagent Vascular announced that it enrolled the first patient in a study comparing its Serranator system to plain old balloon angioplasty (POBA). The prospective, randomized (2:1 treatment to control) dual-center study plans to enroll up to 60 subjects. Investigators intend to use optical coherence tomography (OCT) imaging to demonstrate the … [Read more...] about Cagent Vascular initiates balloon angioplasty study
Elixir Medical launches IVL system in Europe
Elixir Medical announced today that it received CE mark for its LithiX hertz contact (HC) intravascular lithotripsy (IVL) system. The Milpitas, California–based company kicked off its commercial launch for the IVL system in Europe following receipt of CE mark. Dr. Stefano Galli (Centro Cardiologico Monzino in Milan), Dr. Eric Van Belle (Lille … [Read more...] about Elixir Medical launches IVL system in Europe
Medtronic says new study backs Prevail paclitaxel-coated balloon
Medtronic (NYSE: MDT) announced results from a registry highlighting the effectiveness of the Prevail drug-coated balloon (DCB). Dr. Sacharias von Koch of the Deptartment of Cardiology and Clinical Sciences at Lund University, Skåne University Hospital in Sweden presented findings from the Swedish Coronary Angiography and Angioplasty Registry … [Read more...] about Medtronic says new study backs Prevail paclitaxel-coated balloon
Medtronic enrolls first patient in drug-coated balloon study
Medtronic (NYSE: MDT) announced today that investigators enrolled the first patient in a pivotal trial of its Prevail drug-coated balloon (DCB). The study evaluates the paclitaxel-coated balloon catheter for in-stent restenosis (ISR) and de novo small vessel disease. Dr. Ziad Ali, director of the DeMatteis Cardiovascular Institute at St Francis … [Read more...] about Medtronic enrolls first patient in drug-coated balloon study
Medtronic inks stent distro deal with Contego with option to buy
Medtronic (NYSE: MDT)announced today that it entered into an exclusive U.S. distribution agreement with Contego Medical. Under the agreement, Medtronic serves as the sole U.S. distributor for Contego's portfolio of commercially available products. Raleigh, North Carolina-based Contego offers products that provide revascularization treatment for … [Read more...] about Medtronic inks stent distro deal with Contego with option to buy
Boston Scientific makes IVL play with Bolt Medical acquisition
Boston Scientific (NYSE: BSX) announced today that it agreed to acquire intravascular lithotripsy (IVL) platform developer Bolt Medical. On a 100% basis — before considering an existing equity stake and other adjustments — the deal is valued at $600 million upfront with up to an additional $300 million upon achievement of certain regulatory … [Read more...] about Boston Scientific makes IVL play with Bolt Medical acquisition
CardioFocus completes first-in-human pulsed-field ablation case in investigational trial
CardioFocus announced today that investigators completed the first series of treatments in a study of its OptiShot pulsed-field ablation system. The VISION AF clinical trial evaluates OptiShot as a treatment for paroxysmal AFib. Dr. Vivek Reddy of Mount Sinai and Dr. Petr Neužil of Na Homolce Hospital (Prague) performed the first cases. The … [Read more...] about CardioFocus completes first-in-human pulsed-field ablation case in investigational trial
Abbott reports first cases with software-guided balloon-expandable TAVI
Abbott (NYSE:ABT) today announced the first patient procedures with its investigational transcatheter aortic valve implantation (TAVI) system. The company designed its investigational software-guided, balloon-expandable TAVI system to build a foundation for AI-guided procedures. It hopes to add the expandable system to its structural heart … [Read more...] about Abbott reports first cases with software-guided balloon-expandable TAVI
