Deaths, Stroke Risk Halt Sales Of HeartWare Ventricular Assist Device
The FDA and Medtronic warned doctors to cancel any planned implants of Medtronic's HeartWare device. The move comes after reports of deaths and life-threatening events, plus recalls related to wear and tear and pump-starting problems.
FierceBiotech:
As Medtronic Discontinues Faulty HeartWare Device, Abbott Offers Up Its Own Heart Pump To Meet Demand
After three strikes in just the last six months, Medtronic’s implantable heart pump is out. The company issued (PDF) an urgent message Thursday notifying doctors and patients that it would immediately stop selling and distributing the HeartWare Ventricular Assist Device, or HVAD. In the official letter, Medtronic instructs physicians to cancel any new implants of the blood pump, but the company does not recommend removal of any existing implants. It directs the approximately 4,000 patients already implanted with the device to continue using it normally and to contact Medtronic for future replacements of its components. (Park, 6/3)
Bloomberg:
Medtronic Halts Heart Failure HVAD Device Sales As Risks Surface
Medtronic Plc is halting sales of its HVAD device that helps patients with advanced heart failure pump blood on growing evidence that it leads to more strokes and other adverse events than competing models. “The company notified physicians to cease new implants of the HVAD system and transition to an alternative means of durable mechanical circulatory support,” Dublin-based Medtronic said Thursday in a statement. The shares fell as much as 1.2% as of 9:53 a.m. in New York. (Rutherford and Connelly, 6/3)
AP:
FDA Warns Doctors To Stop Using Heart Pump Tied To Deaths
The FDA said Medtronic halted sales after reviewing 100 reports of power failures with the device, which led to 14 patient deaths and 13 patients having it removed. The company previously issued recalls on some Heartware devices and components used when implanting it. In December, the company warned about power failures or delayed restarts with three lots. The company said patients should not automatically have the device removed. Taking out recalled heart implants has to be carefully weighed against the potential risks of surgery. (Perrone, 6/3)
Newsweek:
Medtronic Stops Selling Heart Pump Device Tied To 13 Deaths, FDA Issues Warning
"There have been 29 complaints about this device issue, which include 19 serious injuries and 8 cases of patients who had a life-threatening event but recovered without long term effects," the FDA said in a statement. According to the FDA, the HVAD Pump Implant Kit will sometimes fail to start, causing a delay after the pump has been stopped. This can cause serious injuries or further complicate heart failure problems. (Gile, 6/3)
