Corvention announced today that it received FDA 510(k) clearance for its KardiaPSI balloon catheter device. Flagstaff, Arizona-based Corvention's device is indicated for balloon aortic valvuloplasty (BAV). The company says it provides interventionalists with an ultra-high-pressure solution for the precise dilation of stenotic aortic … [Read more...] about Corvention earns FDA clearance for aortic valve balloon catheter
Balloons
Philips launches new Bridge Plus occlusion balloon
Philips (NYSE:PHG) announced today that it launched its next-generation Bridge Plus occlusion balloon system. Amsterdam-based Philips designed Bridge Plus to help electrophysiology (EP) teams rapidly control bleeding and stabilize patients during rare but life-threatening superior vena cava (SVC) tears in transvenous lead extraction (TLE) … [Read more...] about Philips launches new Bridge Plus occlusion balloon
Medtronic has strong 1-year results for drug-coated balloon
Medtronic (NYSE:MDT) today announced new real-world data from a post-approval study of its In.Pact AV drug-coated balloon (DCB). The IN.PACT AV Access post-approval study demonstrated strong safety and effectiveness for the DCB in the treatment of arteriovenous fistula (AVF) stenoses in patients with end-stage kidney disease on dialysis. The … [Read more...] about Medtronic has strong 1-year results for drug-coated balloon
Stryker makes IVL play with agreement to acquire Amplitude Vascular Systems
Stryker (NYSE:SYK) announced today that it entered into a definitive agreement to acquire Amplitude Vascular Systems (AVS) for an undisclosed amount. Portage, Michigan-based Stryker’s latest strategic move marks its planned entry into the intravascular lithotripsy (IVL) space. IVL remains a hot space, with Johnson & Johnson’s Shockwave … [Read more...] about Stryker makes IVL play with agreement to acquire Amplitude Vascular Systems
MicroPort wins FDA breakthrough nod for drug-eluting stent
MicroPort announced that it received FDA breakthrough device designation for its Apollo Dream sirolimus target-eluting stent system. Apollo Dream, an investigational, balloon-expandable, rapid-exchange drug-eluting stent system, is designed to provide vascular scaffolding and restore. cerebral blood flow. It aims to treat intracranial … [Read more...] about MicroPort wins FDA breakthrough nod for drug-eluting stent
Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient
Airiver Medical announced today that it received FDA breakthrough device designation for its pulmonary drug-coated balloon (DCB). Additionally, Airiver announced the first treated patients in a clinical trial for the DCB. The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. Central airway stenosis … [Read more...] about Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient
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 … [Read more...] about Orchestra BioMed, Terumo terminate drug-eluting balloon distro deal in $30M agreement
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 … [Read more...] about Boston Scientific shares positive Agent drug-coated balloon findings
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 … [Read more...] about Orchestra BioMed enrolls first patient in Sirolumus AngioInfusion balloon trial
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 … [Read more...] about Multiple studies back Cordis Selution SLR drug-eluting balloon
