Cordis recently issued a warning letter regarding an issue with its Smart Flex vascular stent system. Santa Clara, California–based Cordis’s field safety correction action informs users that some of its Smart Flex vascular stents have the potential for distal tip dislodgment or separation due to inadequate adhesive application. Get the full story on our sister […]
Stents
FDA approves Abbott’s next-gen Epic Plus heart valves
Abbott (NYSE:ABT) announced today that it received FDA approval for its Epic Plus and Epic Plus Supra stented tissue valves. The approval offers improved therapy options for people with aortic or mitral valve disease through the next-generation devices that build off of Abbott’s Epic surgical valve platform, according to a news release. Epic Plus, a […]
Ivantis to pay $60M in patent litigation settlement with Glaukos
Glaukos (NYSE:GKOS) announced today that it entered into a settlement with Ivantis to terminate a three-year-old patent infringement lawsuit. San Clemente, California-based Glaukos’ patent infringement lawsuit, initiated on April 14, 2018, in the U.S. District Court for the Central District of California, Southern Division, concerned Ivantis’ Hydrus Microstent for reducing eye pressure in glaucoma patients. Get the full […]
Glaukos submits supplemental PMA application for iStent Infinite
Glaukos (NYSE:GKOS) announced today that it submitted a supplemental premarket approval application to the FDA for its iStent Infinite system. San Clemente, California–based Glaukos designed the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medical therapy. Get […]
Sinomed launches HT Supreme drug-eluting stent in Europe
Sinomed has completed the first commercial implantation of its HT Supreme drug-eluting stent in Ireland. Faisal Sharif, professor of translational cardiovascular medicine and innovation at the National University of Ireland Galway, successfully performed the first procedure with HT Supreme, a healing-targeted drug-eluting stent designed to treat patients with narrowing or blockages to their coronary arteries. Get […]
Cardinal Health completes $1B sale of Cordis business
Cardinal Health (NYSE: CAH) announced today that it has completed the sale of its Cordis business to private equity firm Hellman & Friedman. The $1 billion sales price included includes H&F’s assumption of certain liabilities and Cardinal Health’s retention of some working capital accounts. “As we shared previously, this divestiture demonstrates our disciplined portfolio evaluation […]
Abbott CMO Dr. Nick West touts latest iteration of drug-eluting stent
Abbott executive Dr. Nick West believes the company offers the “best-in-class” drug-eluting stent with its Xience platform. When Abbott (NYSE:ABT) CMO & divisional VP of global medical affairs for its vascular business Dr. Nick West looks back at his use of drug-eluting stents in the early 2000s, all he sees now is innovation. As a practicing interventional cardiologist, West […]
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
Boston Scientific stent recall is Class I
The FDA announced today that it deemed Boston Scientific’s recall of its VICI SDS and VICI RDS venous stent systems as Class I, the most serious kind of recall. Marlborough, Mass.-based Boston Scientific’s VICI SDS and VICI RDS venous stent systems treat obstructions and occlusions in narrowed or blocked venous veins. According to the FDA […]
5 of the latest cardiac tech insights out of ACC.21
The American College of Cardiology’s 70th Annual Scientific Session has produced some positive news about some controversial cardiac tech. Drug-coated stents, which a 2018 study linked to late-stage death, were shown to be non-inferior to non-drug-coated stents in patients with peripheral arterial disease. And a new study of renal denervation that used a different methodology […]
DTW Podcast: Getting to the heart of Boston Scientific’s peripheral business; How Hologic sees trials changing
In this week’s episode of the DeviceTalks Weekly Podcast, Boston Scientific peripheral business EVP Jeff Mirviss explains why the specialty’s name doesn’t really reflect the importance of arteries, veins and other critical “highways” in the body. Mirviss explains where the peripheral business is headed, and why Boston Scientific is uniquely positioned to address the business. […]