The FDA has labeled a recent Abbott (NYSE:ABT) recall of Ellipse implantable cardioverter defibrillators (ICDs) as the most serious type, which could result in patient death. The company began the recall in June, citing damaged wires in 204 Ellipse pacemakers distributed globally. Today’s FDA announcement said that a faulty manufacturing process had left the Ellipse […]
Abiomed stock keeps on sliding
Abiomed (NSDQ:ABMD) shares continued to plummet today following a tough earnings report, closing down -26.45% to $204.87 each. The Danvers, Mass.-based medical device maker reported fiscal first-quarter sales that missed the mark and lowered its top-line outlook on the rest of the year. Abiomed posted profits of $88.9 million, or $1.93 per share, on sales […]
Abiomed plunges on fiscal Q1 earnings miss, lowered outlook
Abiomed (NSDQ:ABMD) shares came under pressure today after the medical device maker reported fiscal first-quarter sales that missed the mark and lowered its top-line outlook on the rest of the year. Danvers, Mass.-based Abiomed posted profits of $88.9 million, or $1.93 per share, on sales of $207.7 million for the three months ended June 3o, […]
Magenta Medical gets funding from U.S.-based VC firm
Miniature heart pump developer Magenta Medical said today that New Enterprise Associates (NEA) has led a financing round for an undisclosed sum. The NEA group includes existing investors such as Pitango Venture Capital and JVC Investment Partners as well as a group of private investors led by Dr. Jacques Seguin, co-founder of ReCor Medical and […]
Getinge recalls cardiac pumps following reports of 5 deaths
Getinge (STO:GETI-B) is recalling four models of Maquet/Datascope intra-aortic balloon pumps (IABP) due to reports of faulty batteries. Five deaths have been reported since March 2016. The IABP batteries failed to hold a charge, stopped unexpectedly, or had a shortened run-time, which may have caused the device to stop working when being operated by battery […]
Medtronic touts stroke data from HeartWare HVAD thoracotomy study
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 […]
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