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 […]
Catheters
CardioFocus wins Japan regulatory approval for HeartLight X3 system
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 home peritoneal catheter system wins expanded FDA clearance
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 wins expanded FDA approval for cryoablation catheters
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, […]
How Abbott engineered a catheter-delivered device for premature babies
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 buys PreCardia and its heart failure treatment system
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, China Grand Pharmaceutical partner to commercialize catheter ablation system in China
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 acquires Distal Solutions
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 […]
Cardiovascular Systems launches peripheral balloon catheter
Cardiovascular Systems (NSDQ:CSII) today said it has launched its OrbusNeich Jade percutaneous transluminal angioplasty over-the-wire balloon catheter in the U.S. Jade is an over-the-wire (OTW) balloon catheter for the peripheral vasculature, including obstructed native arteries and synthetic arteriovenous dialysis fistulae and post-dilation of balloon-expandable and self-expanding stents. Get the full story on our sister site, Medical […]
Olympus acquires Israel-based Medi-Tate
Olympus (TYO:7733) announced that it finalized the acquisition of benign prostatic hyperplasia (BPH) treatment developer Medi-Tate. The Japanese conglomerate did not disclose the financial terms of the acquisition, which was finalized after the company exercised a call option in February, according to a news release. Israel-based Medi-Tate develops the iTind device, which it designed as a […]
Micro Interventional Devices tricuspid annuloplasty system wins FDA breakthrough device designation
Micro Interventional Devices today said it received FDA breakthrough device designation for its MIA-T percutaneous tricuspid annuloplasty system. The MIA-T system treats moderate to severe tricuspid regurgitation through a 12F catheter-based system. Get the full story on our sister site, Medical Tubing + Extrusion.
