FDA warns against use of Medtronic’s HeartWare device for patients with end-stage heart failure

Medtronic had issued an "Urgent Medical Device Communication Notification" announcing its decision to stop the distribution and sale of the HeartWare Ventricular Assist Device

The US Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, has sounded an alarm against the implant of Medtronic’s HeartWare Ventricular Assist Device (HVAD) System to the patients suffering from end-stage heart failure. Back in 2016, HeartWare was acquired by Medtronic for $1.1 billion. Also Read: Cancer treatment: Nanobiotix and LianBio team up, expands therapeutic possibilities for patients with radioenhancer NBTXR3 therapy

Reason for FDA’s advisory: The US FDA has advised against the use of the HeartWare Ventricular Assist Device (HVAD) System owing to a growing observational clinical assessment that revealed a higher frequency of neurological adverse events and mortality linked to the system when compared to other commercially available devices. There have also been complaints that the internal pump sometimes failed to restart or was late in doing so. Also Read: Mankind Pharma launches drug to treat black fungus in India

  • Medtronic’s decision to stop the sale and distribution of the HVAD follows the company’s voluntary recall of a subclass of the HVAD systems in December 2020

Earlier, on June 3, Medtronic had issued an “Urgent Medical Device Communication Notification” announcing its decision to stop the distribution and sale of the HeartWare Ventricular Assist Device (HVAD) System. In its notification letter, Medtronic said, “Physicians should immediately stop new implants of the Medtronic HVAD System”. “Prophylactic explant of the HVAD System is not recommended at this time,” it added. Also Read: Weight Loss: It will now be easier to shed extra pounds after FDA’s nod of approval to anti-obesity drug ‘Wegovy’

The people who’ve already been implanted will now have to wait for a new plan from the device maker including a program for them, their caregivers and their clinical teams. Also Read: Ocugen pays $15 mn to Bharat Biotech for Covaxin rights in Canada

History of HVAD System: Medtronic HVAD system was first approved for commercial use in the U.S. in 2012. The System was meant to be a link to heart transplantation in patients who are at risk of death from end-stage left ventricular heart failure. The System is also meant to buy time for patients’ heart tissue recovery and, as the last stop therapy in patients for whom a heart transplant is not advised.

  • At the time of giving the initial nod to the System in 2012, it had emerged superior to other commercially approved left ventricular assist devices and the benefits of the HVAD System dwarfed the possible risks

What’re they saying: Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health said, “The FDA’s alert is designed to quickly inform health care providers of this critical information so that patients with the current HVAD System continue to receive appropriate care and management. The FDA is committed to facilitating the development of safe and effective devices that can provide patients living with the devastating condition of end-stage heart failure with the opportunity for improved quality of life.”


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