Biotronik said today that it is the first medtech manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a conformity assessment, Biotronik also obtained MDR certification for its quality management system, the Berlin, Germany-based company said. Get the full story on our sister site, Medical Design & […]
Biotronik
Biotronik taps Proximo Medical for U.S. peripheral debut
Biotronik tapped Proximo Medical to guide the U.S. commercialization of its peripheral vascular intervention platform. The German medtech maker’s PVI line includes the Pulsar and Astron stents, the Passeo PTA balloon catheter and Fortress introducer sheath. Castle Pines, Colo.-based Proximo provides market research services to medical device, venture capital and private equity companies. “By partnering […]
ESC Congress 2019: Biotronik beats Abbott at target lesion failure
Biotronik said yesterday that its Orsiro stent tops the Xience stents made by Abbott (NYSE:ABT) when it comes to target lesion failure, according to data from a clinical trial. The randomized, controlled BioSTEMI trial was the first direct comparison between the two drug-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI). Biotronik announced […]
Study: No difference between Biotronik, Medtronic or Boston Scientific stents
A study comparing drug-eluting stents made by Biotronik, Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) found no statistically significant difference on target vessel failure or stent thrombosis after three years. The 3,514-patient Bio-Resort trial compared Biotronik’s Orsiro biodegradable sirolimus-eluting stent, Medtronic’s thin-strut zotarolimus-eluting Resolute Integrity stent and the Synergy biodegradable everolimus-eluting stent. Get the full story at […]
The 17 most innovative medical devices of 2019
The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Nominees need to be FDA approved for market within the last five […]
FDA clears Biotronik’s third-gen injectable cardiac monitor
Biotronik said today that it won 510(k) clearance from the FDA for its Biomonitor III injectable cardiac monitor. Oswego Lake, Ore.-based Biotronik said the Biomonitor III is 60% smaller than its predecessor and offers increased signal quality and a patient app that reports system diagnostics. The device is approved as MR-conditional for both 1.5T and 3.0T […]
Biotronik touts success of its resorbable magnesium scaffold
Biotronik said today that new data from a European patient registry strengthen the clinical evidence for its Magmaris resorbable scaffold device, its procedure success and safety profile. The target lesion failure (TLF) rate at 12 months was 4.7%. Cardiac death occurred in 0.1% of the 800 patients who received Magmaris and scaffold thrombosis in 0.6%. […]
Biotronik launches next-gen ICD, CRT-D trial
Biotronik said yesterday that it launched a study of its new implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems. The BIO|MASTER.Cor Family study will explore clinical safety and workflow benefits of its ICD and CRT-D systems, specifically focused on gains from the thinner and more rounded shape, the Berlin-based company said. Biotrink said that […]
EuroPCR 2019: Elixir Medical touts DynamX
Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases novolimus. […]
Biotronik touts launch of first NICM CRT-D, ICD treatment trial exploring sex-specific outcomes
Biotronik said today that it launched enrollment in what it claims to be the first large-scale prospective study exploring sex-specific outcomes in patients with non-ischemic cardiomyopathy treated with a cardiac defibrillator. The newly launched BIO-LIBRA study aims to enroll up to 1,000 patients, with a minimum of 40% female enrollment, and will explore whether women […]
Biotronik launches PK Papyrus covered coronary stent
Biotronik said today that it’s launching the PK Papyrus covered coronary stent system for acute coronary artery perforations in the U.S. When the FDA granted 510(k) clearance last September, the federal safety watchdog touted it as the first such device to win clearance for that indication in 17 years. About 1% of the 800,000 PCIs […]