Endostart announced today that it received CE mark approval for the expanded use of its flagship Endorail product. Certaldo, Italy-based Endostart designed Endorail to provide efficiency and safety in endoscopic procedures. The technology utilizes a magnetic balloon system to enhance control of the endoscope in both the small and large bowel. It … [Read more...] about Endostart wins CE mark to bring magnetic balloon tech to enteroscopy
Balloons
Abbott progresses pulsed field ablation studies, launches cardiac mapping tool
Abbott today announced new milstones supporting its suite of pulsed field ablation (PFA) solutions in electrophysiology. The company completed enrollment early for its VOLT-AF FDA investigational device exemption (IDE) study evaluating the Volt PFA system. It also launched its FOCALFLEX trial to assess its TactiFlex duo ablation catheter, … [Read more...] about Abbott progresses pulsed field ablation studies, launches cardiac mapping tool
Quasar Medical acquires balloon maker Ridgeback Technologies
Quasar Medical announced that it completed the acquisition of Ridgeback Technologies, a maker of cutting-edge catheter balloons. The company says Galway, Ireland-based Ridgeback's offerings enhance its full-service portfolio of minimally invasive medical devices. The company provides end-to-end manufacturing solutions for such devices and now … [Read more...] about Quasar Medical acquires balloon maker Ridgeback Technologies
Teleflex wins FDA clearance for perfusion balloon for PTCA
Teleflex (NYSE: TFX) announced today that the FDA has granted 510(k) clearance for the company's Ringer perfusion balloon catheter for percutaneous transluminal coronary angioplasty (PTCA). The clearance expands Wayne, Pennsylvania–based Teleflex's interventional cardiology portfolio. It enables the company to offer what it says is the only … [Read more...] about Teleflex wins FDA clearance for perfusion balloon for PTCA
MicroVention launches new stent in the U.S.
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
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
