The FDA last Friday labeled a Medtronic (NYSE:MDT) voluntary select recall of its HeartWare HVAD systems over issues with unexpected power source switching as Class I. A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death. The devices are being recalled over possible interruptions in the […]
Medtronic
EuroPCR Roundup: Biotronik touts two-year study comparing drug-eluting stents
Biotronik yesterday presented two-year data from a trial comparing Boston Scientific‘s (NYSE:BSX) Synergy biodegradable polymer everolimus-eluting stent, Biotronik’s Orsiro sirolimus-eluting stent and Medtronic‘s (NYSE:MDT) Resolute Integrity zotarolimus-eluting stent. Results from the 3,514-patient trial showed no significant difference between the various stents regarding the rate of target vessel failure after two years. But analyses of one-year data found differences between the rates of […]
Medtronic tops estimates with fiscal Q4, 2018 results
Medtronic (NYSE:MDT) today reported fiscal fourth-quarter and 2018 numbers that beat Wall Street’s best guesses for sales and earnings. The Fridley, Minn.-based medical device giant posted profits of $1.46 billion, or $1.07 per share, on sales of $8.14 billion for the three months ended April 27, representing bottom-line growth of 25.5% on sales growth of […]
EuroPCR 2018 Roundup: Medtronic touts BP reductions, no major adverse events in renal denervation trial
Medtronic (NYSE:MDT) today released six-month results from a trial of its Symplicity Spyral renal denervation system exploring its use treating hypertensive patients who are already taking anti-hypertension medications, touting significant reductions in blood pressure and no major adverse safety events. Results were presented at the 2018 EuroPCR annual meeting in Paris and were published in The […]
8 companies commercializing transcatheter mitral valve replacements
Transcatheter mitral valve replacement is a new frontier in the cardio device field, with big legacy medical device companies including Edwards Lifesciences, Medtronic and Abbott spending hundreds of millions of dollars on companies in the space. Much different from transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR) has been mostly experimental. TMVR is used […]
Medtronic recalls select MindFrame Capture revascularization devices
The FDA today released a recall notice for a select number of Medtronic (NYSE:MDT) MindFrame Capture LP revascularization devices over issues with the delivery wire breaking or separating during use. The federal watchdog labeled the recall as a Class I, its most serious class of recall, which indicates the potential for serious injury or death. […]
DHS warns of cybersecurity weakness in Medtronic N’Vision neurostim programmer
The Department of Homeland Security this week released a report warning of cybersecurity vulnerabilities in Medtronic‘s (NYSE:MDT) N’Vision clinician programmer designed for use with neurostimulation devices that could allow outside agents to access personal health data. The DHS said that the vulnerability was originally reported by Whitescope LLC, and requires an individual gain physical access to […]
Medtronic launches study of drug-eluting stent as treatment for bifurcation lesions
Medtronic (NYSE:MDT) today launched a study to evaluate the safety and efficacy of its Resolute Onyx drug-eluting stent for the treatment of bifurcation lesions in patients with coronary artery disease. The medtech giant said that bifurcation lesions make up nearly 20% of all percutaneous coronary interventions. The assessment of DES tech in this patient group is part […]
Medtronic touts data from Micra pacer AV algorithm study
Medtronic (NYSE:MDT) late last week released data from a new clinical study of an algorithm used with its Micra transcatheter pacing system, touting that it has the potential to restore atrioventricular synchrony and improve cardiac function in patients with sinus rhythm and AV block. Results from the study were presented at the Heart Rhythm Society’s annual scientific […]
Medtronic touts improved patient survival in AdaptivCRT algorithm study
Medtronic (NYSE:MDT) today released results from a study of its AdaptivCRT algorithm, touting that the use of the algorithm increased patient survival. Results from the trial were presented last week at the Heart Rhythm Society’s annual scientific sessions in Boston, the Fridley, Minn.-based company said. The AdaptivCRT algorithm is designed to personalize cardiac resynchronization therapy and adjusts […]
HRS 2018 Roundup: Researchers highlight the latest in cardiac ablation tech
There are lots of new opportunities in ablation, evidenced by the research touted at this year’s annual meeting of the Heart Rhythm Society in Boston. Scientists presented data from trials evaluating cardiac ablation via pulsed electric fields, intramural needle ablation and more. Editors at MassDevice.com asked leading cardiac electrophysiologist Dr. Vivek Reddy, will there someday be one […]