InVera Medical announced recently that it picked up European approval for its minimally invasive device for delivering vein treatments. The Galway, Ireland-based company designed its device to help deliver treatment more effectively to diseased leg veins, including varicose veins. CE mark approval enables the marketing of the InVera Infusion Device across the European Union. According […]
Vascular
Orchestra BioMed, Terumo terminate drug-eluting balloon distro deal in $30M agreement
Orchestra BioMed (Nasdaq:OBIO) announced today that it entered into a termination and right of first refusal agreement with Terumo. The agreement relates to the New Hope, Pennsylvania-based company’s Virtue Sirolimus AngioInfusion Balloon (SAB). It supersedes and terminates a prior distribution agreement between the companies and grants Terumo a right of first refusal (ROFR) to acquire […]
Boston Scientific shares positive Agent drug-coated balloon findings
Boston Scientific (NYSE: BSX) today shared findings from new analyses of its Agent drug-coated balloon (DCB). Agent serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation. The paclitaxel-coated balloon transfers a therapeutic dose of drug to the vessel wall, helping to prevent in-stent restenosis (ISR) reoccurrence. The FDA […]
Orchestra BioMed enrolls first patient in Sirolumus AngioInfusion balloon trial
Orchestra BioMed (Nasdaq:OBIO) today announced the first patient enrollments in a study of its Virtue Sirolimus AngioInfusion Balloon (SAB). The FDA investigational device exemption (IDE) trial compares the Virtue SAB to the Boston Scientific Agent paclitaxel-coated balloon. Agent is currently the only FDA-approved drug-coated balloon (DCB) for coronary indication, picking up approval in March. New Hope, […]
Multiple studies back Cordis Selution SLR drug-eluting balloon
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 trials demonstrated positive outcomes that met […]
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 stenosis (airway narrowing) […]
Abbott wins CE mark for Esprit drug-eluting, dissolving scaffold
Abbott (NYSE: ABT) announced today that it received CE mark for its Esprit BTK everolimus-eluting resorbable scaffold system. Esprit BTK offers treatment for people with peripheral artery disease (PAD) below the knee (BTK). Abbott designed it to keep arteries open and deliver the drug everolimus to support vessel healing. Following the therapy, the stent completely […]
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 novo (previously untreated) coronary […]
Medtronic enrolls first patient in study for Onyx liquid embolic system
Medtronic [WtwhTicker symbol=”MDT”](NYSE: MDT)[/WtwhTicker] today announced the first patient enrolled in the PELE trial of its Onyx liquid embolic system (LES). PELE (Peripheral Onyx Liquid Embolic) evaluates the safety of Onyx LES for the embolization of arterial hemorrhage in the peripheral vasculature. Dr. Christopher Stark performed the first procedure at Albany Medical Center. Onyx LES, […]
TriSalus Life Sciences launches new infusion system
TriSalus Life Sciences (Nasdaq:TLSI) announced today that it launched its new TriNav FLX infusion system. TriNav FLX features enhanced trackability and significantly expands the company’s existing TriNav portfolio of products. It offers interventional radiologists more options to select the right product for the right patient, TriSalus said in a news release. According to TriSalus, the […]
