Cordis today announced the initiation of a global registry to track real-world outcomes for the Selution SLR drug-eluting balloon (DEB). Miami Lakes, Florida-based Cordis expects the SELUTION Global Coronary Registry to enroll up to 10,000 patients worldwide. It says that would make it one of the largest coronary DEB registries to … [Read more...] about Cordis launches 10,000-patient registry for drug-eluting balloon
Balloons
FastWave Medical earns nod to begin IVL feasibility study
FastWave Medical announced today that it received Institutional Review Board (IRB) approval to begin a coronary feasibility study. The study utilizes Sola, the company's novel laser intravascular lithotripsy (IVL) system. FastWave partnered with Clinical Accelerator to secure the approval, which paves the way for its planned U.S. pivotal … [Read more...] about FastWave Medical earns nod to begin IVL feasibility study
Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
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
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
