Front Line Medical Technologies today announced that its COBRA-OS bleeding control device won FDA 510(k) clearance. The COBRA-OS (control of bleeding, resuscitation, arterial occlusion system) is a 4 French REBOA (resuscitative endovascular balloon occlusion of the aorta) device that provides full occlusion, intermittent occlusion or partial occlusion depending on a patient’s needs. Get the full story […]
CardioFocus today said it appointed Stephan Ogilvie as chief financial officer. Prior to joining the Marlborough, Mass.-based company, Ogilvie served as managing director of healthcare investment banking at B Riley Securities. He has also served as VP of corporate development at Nuvasive and has held numerous leadership roles at ThinkEquity Partners, Lazard Capital Markets and Medtronic. […]
Boston Scientific (NYSE:BSX) announced today that it exercised its option to acquire the remaining shares of Farapulse. Marlborough, Mass.-based Boston Scientific first announced its intent to acquire Farapulse in September 2020, when it signed an investment agreement with an option to acquire the pulsed-field ablation (PFA) technology developer. Boston Scientific has been an investor in […]
Penumbra (NYSE:PEN) today said its Red 62 reperfusion catheter has received FDA 510(k) clearance. Alameda, Calif.-based Penumbra designed the catheter to navigate complex distal vessel anatomy and deliver powerful aspiration with its Penumbra Engine to remove blood clots in acute ischemic stroke patients with large vessel occlusions. Get the full story on our sister site, Medical […]
CardioFocus today said its HeartLight X3 catheter ablation technology received approval from the Japanese Ministry of Health, Labor and Welfare. Marlborough, Mass.-based CardioFocus designed the catheter ablation technology for controlled and consistent pulmonary vein isolation to treat atrial fibrillation (AFib). Get the full story on our sister site, Medical Tubing + Extrusion.
BD (NYSE:BDX) today said it has received FDA 510(k) clearance for its PeritX peritoneal catheter system. Franklin Lakes, N.J.-based BD designed the catheter system to drain symptomatic, recurrent non-malignant ascites, which causes a build-up of fluid in the abdomen. Get the full story on our sister site, Medical Tubing + Extrusion.
Medtronic (NYSE:MDT) announced today that it received FDA expanded approval for its Arctic Front family of cardiac cryoablation catheters. Fridley, Minn.–based Medtronic’s Arctic Front family of catheters treat recurrent symptomatic paroxysmal atrial fibrillation (AFib) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm control strategy. Get the full story at our sister site, […]
Abbott’s experience designing its Piccolo device provides essential lessons for medical device creators who want to spark a pediatric medical device renaissance. The Amplatzer Piccolo occluder from Abbott is one of the first medical devices that health providers can implant in premature babies weighing as little as 2 lb to treat patent ductus arteriosus (PDA) […]
Abiomed (NASDAQ: ABMD) announced this week that it has acquired PreCardia and its catheter-based system to treat acute decompensated heart failure. The financial terms of the deal were not disclosed in the June 1 announcement. Abiomed officials say the deal complements the company’s product portfolio, expanding options for patients with acute decompensated heart failure. The […]
CardioFocus today announced a licensing and distribution agreement with China Grand Pharmaceutical to seek regulatory approvals for the HeartLight X3 catheter ablation technology in China. Marlborough, Mass.–based CardioFocus designed the HeartLight X3 system for controlled and consistent pulmonary vein isolation, which is the primary treatment for atrial fibrillation (AFib). Get the full story on our […]
Resonetics today said it completed its acquisition of Distal Solutions for an undisclosed amount. Distal Solutions specializes in the design and development of catheter-based delivery systems for medical devices and implants. Distal’s founder David Rezac will lead Resonetics’s design and development efforts and California market expansion. Get the full story on our sister site, Medical Tubing […]