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
Balloons
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
MicroVention announces first U.S. clinical case using aneurysm flow diverter Fred X
MicroVention today announced that the first U.S. clinical case of its flow diverter Fred X device was performed at Thomas Jefferson University Hospital in Philadelphia. Aliso Viejo, California-based MicroVention received premarket approval for the Fred X device in September. It uses a self-expanding braided nitinol mesh to redirect blood flow … [Read more...] about MicroVention announces first U.S. clinical case using aneurysm flow diverter Fred X
The top 10 catheter innovations of 2021
Last year was a big year for catheter innovation as medtech companies large and small received regulatory approvals for devices ranging from TAVR to single-use endoscopes. Catheter innovations weren't limited to just adults; Catheter-deployed devices for premature babies and toddlers were also approved and released. And catheter-based devices … [Read more...] about The top 10 catheter innovations of 2021
