Medtronic‘s (NYSE:MDT) Resolute Onyx 2.0mm drug-eluting stent met its primary endpoint of target lesion failure at 1 year for the treatment of coronary artery disease in extra-small vessels, according to data from the Resolute Onyx 2.0mm trial. The trial enrolled 101 patients with extra-small vessel sizes ranging from 2 millimeters to 2.25 millimeters. Patients treated with […]
Medtronic
Medtronic looks to settle TAVR patent spat with doc inventor
Medtronic (NYSE:MDT) is looking to settle a patent infringement dispute over transcatheter aortic valve replacements with a doctor who sued the company and cross-town rival St. Jude Medical (NYSE:STJ), which last week lost its bid to have the case dismissed. Dr. Robert Snyder, founder of Snyders Heart Valve, filed suits last year in the U.S. District […]
EuroPCR 2017 Roundup: Boston Scientific’s Lotus beats Medtronic’s CoreValve in head-to-head study
Boston Scientific (NYSE:BSX) said its Lotus replacement heart valve beat the competing CoreValve device made by Medtronic (NYSE:MDT) in a head-to-head trial. Data from the Reprise III study, billed as the 1st head-to-head pivotal trial comparing transcatheter aortic valve replacements, were released today at the annual EuroPCR meeting in Paris. The 912-patient study compared Lotus with […]
Report: Layoffs ahead for Medtronic Spine in Memphis
Medtronic (NYSE:MDT) is reportedly planning an unspecified number of layoffs among the 1,300 workers it employs at its Medtronic Spine operation in Memphis. “Medtronic operates in a highly competitive environment, and transformation is an inherent part of our business. We continually adjust as necessary to deliver operational and functional excellence, drive growth, and strengthen our […]
Medtronic options QT Vascular’s Chocolate PTA peripheral balloon
Medtronic (NYSE:MDT) agreed to acquire an option on the Chocolate PTA non-drug-coated balloon made by QT Vascular to treat peripheral vascular disease. The purchase price is $28 million, according to Singapore’s Business Times, pegged to “achievement of certain milestones,” the company said. In February the companies inked a 5-year deal calling for Medtronic to distribute the Chocolate […]
HRS 2017: Medtronic’s Micra leadless pacer performs well in post-approval registry
The Micra leadless pacemaker made by Medtronic (NYSE:MDT) showed a high implant success rate and low rates of major complications in a post-approval registry study released today at the annual Hearth Rhythm Society conference in Chicago. The study followed 795 patients implanted with the Micra device, which won FDA approval in April 2016. The safety endpoint was system- […]
Medtronic wins 1st FDA approval for MRI-safe quad pacers
Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for its line of quadripolar, MRI-safe cardiac resynchronization therapy pacemakers. The approval covers Medtronic’s Percepta, Serena and Solara devices, the Fridley, Minn.-based company said. The devices are slated tho hit the U.S. market in “early summer,” Medtronic said. In February the company said it had won CE […]
FDA labels Medtronic HVAD splice kit recall as Class 1
The FDA today labeled a select recall of Medtronic (NYSE:MDT) HeartWare Splice Kits designed to repair the driveline of its Ventricular Assist Device over electrical and pump stop issues as Class I. Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could […]
Medtronic’s NewPort Medical recalls ventilators over shutdown issues
The FDA today released information on a select recall of Medtronic‘s (NYSE:MDT) Newport HT70 and HT70 Plus ventilators over software issues which could cause unexpected shutdowns. The Newport HT70 and HT70 plus ventilators are designed to provide breathing support for patients in need of mechanical ventilation. The devices can be used with infant, pediatric or […]
FDA warns of 3rd party compatibility issues with Medtronic’s NavLock Trackers
The FDA this week released a letter warning of issues associated with the use of non-Medtronic (NYSE:MDT) surgical stereotaxic navigation instruments with Medtronic’s NavLock Tracker, including multiple injuries and 2 patient deaths. Earlier this week, Medtronic released a related safety notice, saying that it is aware of compatibility issues and urging users of the devices […]
Medtronic wins FDA nod for Resolute Onyx drug-eluting stent
Medtronic (NYSE:MDT) said today that the FDA approved its Resolute Onyx drug-eluting stent. The Fridley, Minn.-based company touted its device as the 1st stent formed by a sinusoidal wave of cobalt alloy wire. The company incorporated a radiopaque inner core within the wire to boost visibility, according to Medtronic. The stent also features thin struts and a polymer […]