Medtronic has stopped the sale and distribution of its HeartWare Ventricular Assist Device (HVAD) system due to evidence that its use may put patients at a serious risk of death or other adverse outcomes. This news is expected to affect approximately 4,000 patients currently implanted with the device.
In Medtronic’s announcement, released June 3, the company cites “a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD system as compared to other circulatory support devices available to patients.”
In addition, there have been ongoing problems with the system’s internal pump stopping and then failing to restart. In a new advisory, also released June 3, the FDA said this issue has led to 14 deaths and 13 pump removals. A recall of some HVAD implant kits was announced back in March 2021.
For new patients in need of a left ventricular assist device (LVAD), the FDA recommends that clinicians choose an alternative solution, specifically listing Abbott’s HeartMate 3 LVAD as one example. Care should continue as previously scheduled for patients currently implanted with the device—but clinicians are asked to contact Medtronic as needed to obtain replacement parts for peripheral components.
“The FDA has monitored the performance of the Medtronic HVAD System since it was approved in 2012, including monitoring neurological adverse event rates,” according to the agency’s advisory. “Although Medtronic has stopped the sale and distribution of new HVAD Systems, the FDA will continue to monitor the safety and effectiveness of the HVAD systems that remain implanted.”
“There is nothing more important than the safety and well-being of patients,” Nnamdi Njoku, president of Medtronic’s Mechanical Circulatory Support Business, said in a prepared statement. “We recognize this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them in coordination with their physicians.”
Read the full FDA advisory here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.