The FDA issued healthcare providers updated guidance for certain warning language with paclitaxel-coated devices that treat PAD. These peripheral arterial disease (PAD)-treating devices produced data that does not support an excess mortality risk. Specifically, the FDA's guidance eliminates the need for certain warning language in the device … [Read more...] about FDA updates guidance on paclitaxel-coated devices, determines no link to late mortality risk
Balloons
Cook Medical has more hydrophilic PTA balloon catheter options
Cook Medical today announced more sizes and locations for the Advance Serenity hydrophilic PTA balloon catheter product line. It's now possible for U.S. and Canadian interventionalists to use Advance Serenity for below-the-knee and above-the-knee procedures to treat patients with peripheral artery disease (PAD), according to Cook Medical. In … [Read more...] about Cook Medical has more hydrophilic PTA balloon catheter options
FDA approves Surmodics SurVeil drug-coated balloon
Surmodics (Nasdaq:SRDX) announced today that the FDA granted approval for its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota–based Surmodics may now market and sell SurVeil in the U.S. for percutaneous transluminal angioplasty. Use follows appropriate vessel preparation or de novo or restenotic lesions in femoral and popliteal … [Read more...] about FDA approves Surmodics SurVeil drug-coated balloon
FDA clears Pounce LP thrombectomy system from Surmodics
Surmodics (Nasdaq:SRDX) today announced that it received FDA 510(k) clearance for its Pounce low-profile (LP) thrombectomy system. News of the regulatory nod comes just one day after Needham analysts upgraded Surmodics stock from "Hold" to "Buy." The analysts cited positive developments pointing toward the likely approval of Surmodics' SurVeil … [Read more...] about FDA clears Pounce LP thrombectomy system from Surmodics
How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
Tim Laske, VP of research and business development for Medtronic‘s cardiac ablation solutions business, discusses the challenges of designing devices for the heart and explores the properties of nitinol. The heart is often one of the most underappreciated aspects of human anatomy, and its atrial appendages are often overlooked even in cardiac … [Read more...] about How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
Getinge’s Datascope has its second Class I recall in a month
The FDA issued a notice determining another recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate Class I recall earlier this month. The … [Read more...] about Getinge’s Datascope has its second Class I recall in a month
Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is … [Read more...] about Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Getinge wins FDA PMA for iCast covered stent
Getinge recently announced its iCast covered stent received FDA premarket approval to treat patients with iliac arterial occlusive disease. The iCast covered stent is a clinically-evaluated balloon expandable polytetrafluoroethylene-covered stent. It is delivered using a catheter to hold open and support the walls of structures within the body. … [Read more...] about Getinge wins FDA PMA for iCast covered stent
Getinge’s Datascope has another serious intra-aortic balloon pump recall
The FDA issued a notice determining a recall of Getinge subsidiary Datascope's Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company's Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in … [Read more...] about Getinge’s Datascope has another serious intra-aortic balloon pump recall
Surmodics is laying off roughly 60 workers
Surmodics (Nasdaq: SRDX) announced a restructuring that includes cutting 13% of the workforce at the Eden Prairie, Minnesota-based IVD tech developer. In its most recent annual report, Surmodics listed a headcount of 447, which means the layoff could involve nearly 60 workers. The cost-reduction plan will save roughly $10 million to $11 million … [Read more...] about Surmodics is laying off roughly 60 workers
