A retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump. The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance […]
HeartWare International Inc.
Medtronic’s HeartWare to settle investor suit for $55m
Medtronic (NYSE:MDT) subsidiary HeartWare International agreed to settle a class-action lawsuit brought over a failed trial of its MVAD implantable heart pump. The lawsuit’s origins lie in the July 2015 launch of a clinical trial aimed at winning CE Mark approval in the European Union for HeartWare’s next-generation MVAD pump. The company hit the pause button in September 2015 after running into an issue with […]
Medtronic’s HeartWare can’t slip investors class action over failed MVAD trial
A federal judge in New York City last week shot down a bid by Medtronic subsidiary HeartWare to dismiss a class-action lawsuit brought over a failed trial of its MVAD implantable heart pump. Framingham, Mass.-based HeartWare in July 2015 launched a clinical trial aimed at winning CE Mark approval in the European Union for the next-generation […]
Shockwave Medical picks up ex-HeartWare CEO Godshall | Personnel Moves – May 11, 2017
Shockwave Medical said today it tapped former HeartWare CEO Doug Godshall as its new prez & CEO. Godshall served as CEO of HeartWare for 10 years until the business was acquired by Medtronic (NYSE:MDT) for $1.1 billion last August, Fremont, Calif.-based Shockwave Medical said. Prior to his time at HeartWare, Godshall held various executive and leadership […]
ISHLT 2017: Medtronic HVAD trial misses primary endpoint, reports lowered stroke rates
Medtronic (NYSE:MDT) said today that results from the Endurance supplemental trial of its HVAD heart pump system did not meet its primary endpoint, but did report lowered stroke rates compared to standard treatment. The trial aimed to evaluate the use of the HVAD system, which it picked up along with HeartWare last year, as a destination […]
Medtronic’s HeartWare launches new HVAD controller, recalls older models
The HeartWare subsidiary Medtronic (NYSE:MDT) acquired for $1 billion last year is launching a new controller for its HVAD left ventricular assist devices and recalling older versions of the device. Issues with the implantable heart pump’s controller date back to at least April 2010, when HeartWare said a July 2009 redesign aimed at waterproofing the controllers inadvertently made them […]
Medtronic wins EU nod for less-invasive HVAD implant procedure
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a less-invasive implant procedure for the HVAD system left ventricular assist device it acquired along with HeartWare in August. The new implantation procedure uses a smaller incision than the previously cleared procedure, Fridley, Minn.-based Medtronic said, potentially lessening bleeding and related […]
FDA updates on 2 Class I HeartWare HVAD recalls
Correction: A previous version of this article identified this as a new set of recalls, due to differing product codes and recall counts. This was incorrect, and updated with information from Medtronic/HeartWare. The FDA today released updated information on Class I recalls for Medtronic‘s (NYSE:MDT) HeartWare Ventricular Assist Devices, affecting a total of 4,669 units. A Class […]
FDA posts another Class I HeartWare HVAD recall
The FDA today posted a Class I recall notice for select Medtronic (NYSE:MDT) HeartWare ventricular assist device controllers over issues with loose power connectors that could stop the pump from functioning. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according […]
Medtronic recalls Heartware HVADs over driveline contamination issues
The FDA today released a recall notice for Medtronic (NYSE:MDT) subsidiary HeartWare International‘s Heartware Ventricular Assist Device over issues with driveline connector tubes of select units which may cause the pump to stop. The federal watchdog labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or […]
Medtronic’s HeartWare faces 2 Class I FDA recalls
Medtronic (NYSE:MDT) said today the FDA labeled 2 outstanding global voluntary recalls related to subsidiary HeartWare International‘s HVAD system as Class 1. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. The voluntary recall is related […]
