Medtronic (NYSE:MDT) today touted stroke data from the Lateral trial of its HeartWare HVAD left ventricular assist device involving implantation via thoracotomy instead of open surgery. With a thoracotomy implantation, surgeons insert the pump via a small, lateral incision between the left ribs and make a second small incision to accommodate the pump’s outflow graft. […]
Philips issues another external defibrillator warning
Philips Healthcare (NYSE:PHG) is alerting customers worldwide that an AC power module in its HeartStart MRx defibrillator/monitor may fail at a higher-than-expected rate. In a letter dated “June 2019,” the company said the problems could stem from an internal component failure, excess solder during manufacture, physical damage in the field, or the power module reaching […]
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 […]
Zeller Power earns first FDA warning letter over UDI compliance
An FDA inspection netted Zeller Power Products (Wallace, Idaho) a warning letter citing quality violations that led to adulterated defibrillator batteries. Specifically, the agency discovered during its Nov. 6-9, 2018 inspection of that the firm didn’t have design validation documentation for its automated external defibrillator battery. The design validation documentation was needed to justify the […]
FDA: Survival rates still low for Impella RP patients outside narrow patient selection criteria
The FDA today updated data from a post-approval study of Abiomed‘s (NSDQ:ABMD) Impella RP heart pump system, reporting a new 30-day survival rate of 28.6% for patients post-explant, hospital discharge or the start of longer term therapy. A total of 12 of the 42 patients enrolled in the post-market trial of the Danvers, Mass.-based medtech […]
Abiomed launches Impella CP SmartAssist platform
Abiomed (NSDQ:ABMD) said today it is launching its Impella CP with SmartAssist, which won FDA approval last March. The launch will begin alongside the 2019 Society for Cardiovascular Angiography & Interventions Scientific Sessions which begins on Sunday, the Danvers, Mass.-based company said. The Impella CP with SmartAssist features improvements intended to simplify patient management, integrate clinical data […]
Abiomed wins expanded, 14-day indication for Impella pumps
Abiomed (NSDQ:ABMD) said today that it won an expanded indication from the FDA for two of its Impella heart pumps, extending their indwell times from six to 14 days. The federal safety watchdog’s decision affects the Impella 5.0 and Impella LD devices used to treat cardiogenic shock, Danvers, Mass.-based Abiomed said. The company won the […]
Ex-Abiomed exec looks to keep wrongful termination suit alive
A former Asia VP for Abiomed (NSDQ:ABMD) is hoping to keep a wrongful termination lawsuit alive in a U.S. federal appeals court. In January Keisuke Suzuki lost a lawsuit seeking $2.1 million in damages for unfair termination and denial of an options deal tied to Japanese approval of Abiomed’s Impella heart pump. The Danvers, Mass.-based company […]
HRS 2019: Study shows no danger to CRM devices from airport body scans
Airport body scanners don’t appear to interfere with pacemakers and defibrillators, and noninvasive neurostimulation through the ear may help treat AFib. Those are but some of the insights coming out of the Heart Rhythm Society’s annual scientific sessions, held this week in San Francisco. Here are some of the research highlights coming out of the […]
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 […]
Abiomed wins FDA nod for STEMI Impella trial, sees shares drop on Q4 sales miss
Abiomed (NSDQ:ABMD) said today that the FDA approved the launch of a trial exploring its Impella CP Heart pump’s ability to treat patients undergoing treatment for a STEMI heart attack, and saw shares drop after releasing fourth quarter and full year fiscal 2019 earnings that missed sales expectations on Wall Street. The Danvers, Mass.-based company said […]
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