Terumo subsidiary MicroVention announced that it began the U.S. launch of its LVIS EVO intraluminal support device. The device is now available in the U.S. for the treatment of wide-neck intracranial aneurysms. Aliso Viejo, California-based MicroVention first launched the device in Europe in 2019, selling more than 12,000 units … [Read more...] about MicroVention launches new stent in the U.S.
Cordis reports positive 2-year data for drug-eluting balloon
Cordis today announced positive 24-month results from a study evaluating its Selution SLR drug-eluting balloon (DEB). Selution SLR offers endovascular therapy for de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA). Cordis acquired the DEB technology from MedAlliance for $1.135 billion … [Read more...] about Cordis reports positive 2-year data for drug-eluting balloon
AtHeart Medical reports positive data for ASD occluder with bioresorbable frame
AtHeart Medical today announced positive long- and short-term clinical outcomes for its reSept atrial septal defect (ASD) occluder. Data from three patient cohorts showed positive efficacy and safety outcomes for the occluder, which features a bioresorbable, metal-free frame. AtHeart says it's the first ASD occluder with this kind of frame. It … [Read more...] about AtHeart Medical reports positive data for ASD occluder with bioresorbable frame
Penumbra launches duo of stroke catheters in Europe
Penumbra (NYSE:PEN) announced today that, with CE mark approval, it launched its new BMX81 and BMX96 neuro access devices in Europe. The company designed the devices for the neurovascular management of ischemic and hemorrhagic stroke. Penumbra said they represent its "most advanced neuro access offerings," according to a news release. The launch … [Read more...] about Penumbra launches duo of stroke catheters in Europe
Smiths Medical warns on some Bivona tracheostomy tubes, death reported
ICU Medical's Smiths Medical issued an urgent field safety notice to warn of a potential defect with some of its Bivona tracheostomy products. Posted out of Germany, the warning applies to a number of Bivona neonatal/pediatric and adult tracheostomy tubes. That includes the Aire-Cuf, TTS, Uncuffed and Mid-Range Bivona tubes for … [Read more...] about Smiths Medical warns on some Bivona tracheostomy tubes, death reported
CardioFlow wins CE mark for VitaFlow Liberty TAVI system
MicroPort CardioFlow Medtech Corp. today announced that it received CE mark for its second-generation aortic valve implant. The VitaFlow Liberty transcatheter aortic valve implant (TAVI) device and retrievable delivery system received EU CE-MDR certification. CardioFlow's implant helps patients avoid open-heart surgery and delivers minimal … [Read more...] about CardioFlow wins CE mark for VitaFlow Liberty TAVI system
Medtronic launches Steerant aortic guidewire
Medtronic (NYSE:MDT) today announced the launch of its Steerant aortic guidewire in the U.S. and Canada following the first patient cases. The medtech giant tailored Steerant to facilitate catheter placement and exchange during diagnostic or interventional aortic procedures. It designed the guidewire to support endovascular aneurysm repair … [Read more...] about Medtronic launches Steerant aortic guidewire
Emergency Scientific announces first use of balloon catheter
Emergency Scientific announced the first patient use of its Landmark resuscitative endovascular occlusion of the aorta (REBOA) catheter. Salt Lake City-based Emergency Scientific developed Landmark for REBOA, a procedure developed by the military. It aims to treat hemorrhage from non-compressible fractures of the pelvis and penetrating trauma of … [Read more...] about Emergency Scientific announces first use of balloon catheter
Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
The FDA says a recall of Teleflex (NYSE:TFX) intra-aortic balloon (IAB) catheter kits is Class I, the most serious kind of recall. Teleflex recalled its Arrow FiberOptix IAB catheter kit and Arrow UltraFlex IAB catheter kit. This recall is a correction, not a product removal. However, the issues related to the kits resulted in reports of 31 … [Read more...] about Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial
Xeltis announced today that it received FDA investigational device exemption (IDE) to begin a pivotal study of its restorative vascular access conduit. aXess enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of arteriovenous fistula (AVF) with the speed to treatment of … [Read more...] about Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial
