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Structural Heart

Zoll loses bid to dismiss LifeVest lawsuit

August 15, 2019 By Nancy Crotti

A federal judge has denied Asahi Kasei (TYO:3407) subsidiary Zoll Medical’s motion to toss out a lawsuit filed by the family of a woman who attribute her death to a faulty Zoll LifeVest wearable defibrillator. U.S. District Court Judge Darrin Gayles in the Southern District of Florida also halted Zoll’s effort to bar evidence from the plaintiffs’ […]

Filed Under: Featured, Legal News, News Well, Product Liability, Structural Heart Tagged With: Zoll Medical

Abiomed wins extended Medicare coverage for Impella

August 14, 2019 By Nancy Crotti

Abiomed (NSDQ:ABMD) has won a one-year reprieve from a proposed 27% Medicare reimbursement cut to hospitals for the use of its Impella ventricular support device. In April, the Centers for Medicare & Medicaid Services (CMS) floated the rate cut proposal for inpatient surgeries involving external assist devices inserted into the heart, such as Impella. The […]

Filed Under: Business/Financial News, Featured, Hospital Care, Medicare, News Well, Structural Heart Tagged With: Abiomed, Centers for Medicare and Medicaid Services (CMS)

Ancora Heart launches AccuCinch study in Europe

August 12, 2019 By Nancy Crotti

Ancora Heart said today that the first patient was enrolled in a European multi-center clinical evaluation of its AccuCinch ventricular repair system intended for treating patients with reduced ejection fraction systolic heart failure. The first patient was enrolled at Homolka Hospital in Prague, Czech Republic, by Dr. Petr Neužil, head of the hospital’s cardiology department […]

Filed Under: Clinical Trials, Featured, News Well, Structural Heart Tagged With: Ancora Heart

FDA slaps Abbott ICD recall with Class I label

August 5, 2019 By Nancy Crotti

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 […]

Filed Under: Blog, Featured, Food & Drug Administration (FDA), News Well, Recalls, Structural Heart Tagged With: Abbott, FDA

Abiomed stock keeps on sliding

August 1, 2019 By Nancy Crotti

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 […]

Filed Under: Featured, MassDevice Earnings Roundup, Structural Heart, Wall Street Beat Tagged With: Abiomed

Abiomed plunges on fiscal Q1 earnings miss, lowered outlook

August 1, 2019 By Brad Perriello

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, […]

Filed Under: Featured, MassDevice Earnings Roundup, Structural Heart, Wall Street Beat Tagged With: Abiomed

Magenta Medical gets funding from U.S.-based VC firm

July 29, 2019 By Nancy Crotti

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 […]

Filed Under: Blog, Business/Financial News, Featured, Funding Roundup, News Well, Research & Development, Structural Heart Tagged With: magentamedical, New Enterprise Associates

Getinge recalls cardiac pumps following reports of 5 deaths

July 24, 2019 By Nancy Crotti

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 […]

Filed Under: Food & Drug Administration (FDA), Recalls, Structural Heart Tagged With: Datascope, FDA, Getinge, Maquet

Medtronic touts stroke data from HeartWare HVAD thoracotomy study

July 8, 2019 By Brad Perriello

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. […]

Filed Under: Cardiovascular, Clinical Trials, Featured, Structural Heart Tagged With: Medtronic

Philips issues another external defibrillator warning

June 27, 2019 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Featured, News Well, Patient Monitoring, Structural Heart Tagged With: Philips

Biotronik launches next-gen ICD, CRT-D trial

May 28, 2019 By Fink Densford

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Structural Heart Tagged With: Biotronik

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