Cordis today announced new findings from a duo of studies supporting the use of its Selution SLR drug-eluting balloon (DEB) system. Miami Lakes, Florida-based Cordis announced results from the SELUTION DeNovo and SELUTION 4ISR trials at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Both randomized clinical … [Read more...] about Multiple studies back Cordis Selution SLR drug-eluting balloon
Balloons
Merit Medical to acquire cryoballoon tech from Pentax
Merit Medical Systems (Nasdaq:MMSI) announced an agreement to acquire the C2 CryoBalloon device from a Pentax Medical subsidiary. South Jordan, Utah-based Merit signed a definitive asset purchase agreement with Pentax of America over the C2 CryoBalloon and related technology. The companies expect the closing of the deal to occur during the fourth … [Read more...] about Merit Medical to acquire cryoballoon tech from Pentax
Medtronic launches full U.S. distribution of Neuroguard IEP carotid stent system
Medtronic today announced the full U.S. rollout of the Neuroguard IEP system, a carotid stent and embolic protection device. The launch follows a limited market release and builds on Medtronic’s exclusive U.S. distribution agreement with the device’s developer Contego Medical. Neuroguard IEP combines a nitinol stent, dilation balloon and … [Read more...] about Medtronic launches full U.S. distribution of Neuroguard IEP carotid stent system
Airiver Medical wins FDA IDE for pulmonary drug-coated balloon
Airiver Medical announced today that it received FDA investigational device exemption (IDE) for its pulmonary drug-coated balloon (DCB). The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. This FDA IDE – the company's first — allows it to begin a pivotal clinical trial of the technology. Central airway … [Read more...] about Airiver Medical wins FDA IDE for pulmonary drug-coated balloon
Boston Scientific launches head-to-head drug-coated balloon trial
Boston Scientific (NYSE:BSX) announced today that it initiated a new trial to assess its Agent DCB compared to the standard of care. The AGENT DCB STANCE trial pits the drug-coated balloon (DCB) head-to-head against percutaneous coronary intervention (PCI) treatment with drug-eluting stents (DES) and/or balloon angioplasty – in patients with de … [Read more...] about Boston Scientific launches head-to-head drug-coated balloon trial
Boston Scientific earns Medicare reimbursement for Agent drug-coated balloon
Boston Scientific (NYSE: BSX) announced today that CMS granted reimbursement for its Agent drug-coated balloon (DCB). CMS granted a new technology add-on payment (NTAP) for eligible cases using Agent. NTAP provides additional reimbursement to hospitals that use designated new medical technologies in the first few years of market introduction. … [Read more...] about Boston Scientific earns Medicare reimbursement for Agent drug-coated balloon
AngioDynamics enrolls first patient in atherectomy system study
AngioDynamics (Nasdaq:ANGO) announced today that it enrolled the first patient in a randomized study of its Auryon atherectomy system. The AMBITION BTK study looks at Auryon in combination with standard balloon angioplasty in treating infrapopliteal lesions in subjects with critical limb ischemia below the knee. It compares this therapy method to … [Read more...] about AngioDynamics enrolls first patient in atherectomy system study
BD warns on esophagogastric balloon tamponade tubes after death
The FDA issued a notice highlighting a letter issued by BD and its C.R. Bard Urology and Critical Care subsidiary warning of new balloon device instructions. This warning follows one death associated with the device issue. BD sent affected customers a notice updating instructions for all lots of certain esophagogastric balloon tamponade tubes. … [Read more...] about BD warns on esophagogastric balloon tamponade tubes after death
Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
Medtronic announced today that it received CE mark for several expanded indications for its Prevail balloon catheter. The expanded indications for the paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter (or drug-coated balloon/DCB) cover the treatment of coronary artery disease (CAD). According to the medtech … [Read more...] about Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
Cordis launches 10,000-patient registry for drug-eluting balloon
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
