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
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Abbott imaging catheter recall flagged as Class I by FDA
The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That's the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The recall affects … [Read more...] about Abbott imaging catheter recall flagged as Class I by FDA
FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent (DES). Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, … [Read more...] about FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
FDA warns of potential toxic risk from Fresenius hemodialysis machines
The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines. The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K. The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL … [Read more...] about FDA warns of potential toxic risk from Fresenius hemodialysis machines
Recall of Medtronic’s Harmony delivery catheter is Class I
The FDA today announced a Class I recall — the most serious kind — for the Medtronic (NYSE:MDT) Harmony delivery catheter system. Medtronic designed the Harmony transcatheter pulmonary valve (TPV) system for treating a leaky native or surgically repaired right ventricular outflow tract (RVOT). It consists of a transcatheter pulmonary valve and a … [Read more...] about Recall of Medtronic’s Harmony delivery catheter is Class I
Getinge intra-aortic balloon pump recall is Class I
The FDA determined that Getinge's recall of its Cardiosave Hybrid and CardioSave Rescue devices is Class I, the most serious kind. Datascope/Getinge/Maquet designed the CardioSave Hybrid and CardioSave Rescue intra-aortic balloon pumps (IABP) as cardiac assist devices for patients undergoing cardiac and non-cardiac surgery. They are used in … [Read more...] about Getinge intra-aortic balloon pump recall is Class I
ALung Technologies wins FDA de novo nod for Hemolung respiratory assist system
ALung Technologies announced today that it received FDA de novo clearance for its Hemolung respiratory support platform. Pittsburgh-based ALung designed its Hemolung system to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) for patients with acute respiratory failure. Get the full story at our sister site, MassDevice. … [Read more...] about ALung Technologies wins FDA de novo nod for Hemolung respiratory assist system
What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains
Medtronic (NYSE:MDT) continues clinical trials of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. The hope now is to win FDA approval in 2023. To better understand the technology behind what Medtronic leaders expect to become a multibillion-dollar business, Medical Design & Outsourcing spoke with Jason … [Read more...] about What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains
Medtronic faces longer road to renal denervation
Medtronic (NYSE:MDT) will continue the clinical study of its Symplicity Spyral renal denervation (RDN) system for hypertension into next year after lacking the positive results needed to end enrollment early. Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular … [Read more...] about Medtronic faces longer road to renal denervation
Medtronic’s Pipeline Flex problems expand
The FDA today issued a notice confirming a Class I recall of the Pipeline Flex embolization device from Medtronic (NYSE:MDT). Several models of the Pipeline Flex embolization device and Pipeline Flex embolization device with Shield Technology were affected, with 8,825 devices recalled in the U.S., having been distributed between April 18, 2019, … [Read more...] about Medtronic’s Pipeline Flex problems expand
