MedAlliance this week announced its Selution SLR sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE) approval to begin a clinical trial for occlusive disease of the superficial femoral artery (SFA). The second IDE approval comes a few months after the Geneva, Switzerland-based company won IDE approval for … [Read more...] about MedAlliance sirolimus-eluting balloon wins second FDA IDE
Balloons
Advanced NanoTherapies closes $7.2M Series A for drug-coated balloon
Advanced NanoTherapies announced today that it closed an oversubscribed Series A equity financing round. Los Gatos, California-based Advanced NanoTherapies, which develops the SirPlux Duo drug-coated balloon (DCB) for treating de novo coronary artery disease (CAD) lesions, has now raised $12.5 million in total since September 2020. Get the full … [Read more...] about Advanced NanoTherapies closes $7.2M Series A for drug-coated balloon
Philips announces positive three-year results for its Tack endovascular system
Philips this week announced the latest results from its Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial. Amsterdam-based Royal Philips designed Tack to provide a sustained treatment effect and positive impact on quality of life for patients with critical limb ischemia (CLI), a severe stage of peripheral arterial … [Read more...] about Philips announces positive three-year results for its Tack endovascular system
Biomerics opens first European research & development facility
Biomerics this week announced it opened a 2,000 sq. ft research and development facility in Galway, Ireland. The new Balloons and Balloons Catheters Center of Excellence will be the first facility in Europe and the second facility outside of the U.S. It will act as an extension to its Athens, Texas operations and will be dedicated to the … [Read more...] about Biomerics opens first European research & development facility
FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota–based Medtronic's In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral … [Read more...] about FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Medtronic issues voluntary recall for certain In.Pact drug-coated balloon catheters
Medtronic (NYSE:MDT) announced today that it voluntarily recalled a subset of its In.Pact Admiral and In.Pact AV balloon catheters. The company initiated the recent recall of the paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility. Get the full … [Read more...] about Medtronic issues voluntary recall for certain In.Pact drug-coated balloon catheters
Endovastec Hyperflex balloon catheter wins marketing nod in Japan
Endovastec today announced it received registration approval from Japan Pharmaceuticals and Medical Devices Agency for its Hyperflex balloon catheter. The Shanghai-based heart device maker designed Hyperflex to assist in the dilation of aortic stent graft. It is the company's first device approved for marketing in Japan. Hyperflex previously … [Read more...] about Endovastec Hyperflex balloon catheter wins marketing nod in Japan
Medtronic launches NuVent eustachian tube dilation balloon
Medtronic (NYSE:MDT) today announced that it launched its NuVent eustachian tube dilation balloon to treat chronic, obstructive eustachian tube dysfunction. The medtech giant designed the NuVent balloon to allow surgeons to deliver treatment in an outpatient setting. It has a flexible balloon section that creates a customized placement option … [Read more...] about Medtronic launches NuVent eustachian tube dilation balloon
Cardiovascular Systems, Innova Vascular partner to develop thrombectomy devices
Cardiovascular Systems (NSDQ:CSII) announced that it has partnered with Innova Vascular to develop a full line of thrombectomy devices. Under the terms of the agreement, Cardiovascular Systems (St. Paul, Minnesota) will provide financing to Innova (Irvine, California) to develop thrombectomy devices to remove blood clots from arteries and veins. … [Read more...] about Cardiovascular Systems, Innova Vascular partner to develop thrombectomy devices
Front Line Medical expands availability of COBRA-OS arterial occlusion system
Front Line Medical recently announced that it expanded the availability of its COBRA-OS aortic occlusion device to meet growing demands. The Ontario, Canada-based company is increasing production of the COBRA-OS (control of bleeding, resuscitation, arterial occlusion system) occluder following patient success rates and expanded interest from … [Read more...] about Front Line Medical expands availability of COBRA-OS arterial occlusion system
