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HeartWare Ventricular Assist Device Sales Stopped by Medtronic

Medtronic stated today that its HeartWare Ventricular Assist Device (HVAD) system would no longer be distributed or sold. Fridley, Minnesota-born According to a news release, Medtronic issued a notification to physicians this morning instructing them to stop implanting the HeartWare Ventricular Assist Device device and switch to an alternative form of durable mechanical circulatory support.

The business stated it is working on a support program for patients who have had an HeartWare Ventricular Assist Device implanted to assure their continuous care and safety. There are about 4,000 of these individuals. For the same reasons as Medtronic, the FDA released a statement advising providers not to install the HeartWare Ventricular Assist Device system. Dr. Bram Zuckerman, head of the FDA’s Center for Devices & Radiological Health’s Office of Cardiovascular Devices, said the agency is working closely with Medtronic to “ensure patient care is optimised” while the device is phased out.

A growing body of observational clinical comparisons demonstrates a higher frequency of neurological adverse events and mortality associated with Medtronic’s Heartware Ventricular Assist Device (HVAD) System. Compared to other commercially available devices, the US Food and Drug Administration warns health care providers, not to implant end-stage heart failure patients with the system.

According to Medtronic, the decision was made after many clinical studies revealed a higher prevalence of neurological adverse events, such as stroke and mortality, with the HeartWare Ventricular Assist Device device. In February, the device was recalled after 855 complaints, and eight injuries were linked to a problem with the device’s ports. In that recall, Medtronic recorded 12 deaths among implanted patients, three unrelated to the issue at hand.

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