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.
Balloons
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
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
Surmodics to be acquired by private equity firm for $627M
Surmodics (Nasdaq:SRDX) announced today that it agreed to be acquired by GTCR, a private equity firm with healthcare interests. Eden Prairie, Minnesota-based Surmodics develops a range of technologies, including drug-coated balloons and thrombectomy systems. Its SurVeil DCB received a long-awaited FDA approval in June 2023. The company also … [Read more...] about Surmodics to be acquired by private equity firm for $627M
Concept Medical enrolls first patient in drug-coated balloon study
Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system. MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in … [Read more...] about Concept Medical enrolls first patient in drug-coated balloon study
Getinge wins European approval for covered stent system
Getinge announced today that it received EU MDR certification for its Advanta V12 covered stent system for patients with aortoiliac occlusive disease (AIOD). The balloon-expandable covered stent's indication aligns with AIOD, which includes treating lesions at the aortic bifurcation. Getinge said EU MDR certification highlights its dedication … [Read more...] about Getinge wins European approval for covered stent system
Nectero Medical closes $96M Series D
Nectero Medical announced today that it closed a Series D financing round worth proceeds of $96 million. Norwest Venture Partners led the round. Boston Scientific, BioStar Capital, Cadence Healthcare Ventures, Aphelion Capital and other firms contributed large investments. Funds add to a $19.5 million Series C — for which Boston Scientific led … [Read more...] about Nectero Medical closes $96M Series D
Concept Medical wins FDA IDE for MagicTouch AVF drug-coated balloon
Concept Medical today announced it received FDA investigational device exemption for its MagicTouch AVF Sirolimus drug-coated balloon (DCB) catheter. The IDE allows the Tampa, Florida-based company to start a clinical study to treat stenotic lesions of arteriovenous fistula (AVF) in the hemodialysis management of chronic renal failure. "This … [Read more...] about Concept Medical wins FDA IDE for MagicTouch AVF drug-coated balloon
Boston Scientific has positive Agent DCB study results
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue … [Read more...] about Boston Scientific has positive Agent DCB study results
