Medtronic has stopped the distribution and sale of the HVAD™ System as of June 3, 2021 and has notified physicians to cease new implants of the HVAD System and transition to an alternative commercially available LVAD for all future implants. Replacement of the HVAD System is not recommended at this time for patients who currently have the device because, in the vast majority of cases, the risks associated with additional surgery outweighs the benefit of a replacement device. If you have questions about this, please contact your healthcare provider.
Medtronic initiated this action in light of a growing body of observational clinical comparisons demonstrating a higher frequency of neurologic adverse events, including stroke, and mortality with the HVAD™ System as compared to other commercially available LVAD.
In addition, Medtronic previously made an Urgent Medical Device Communication informing physicians that the HAD pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalisation, and result in death.
Considering these findings and the availability of alternative devices, Medtronic made the decision to stop the distribution and sale of the HVAD System, consistent with its commitment to prioritise patient safety.
Medtronic is doing everything possible to minimise any risks to your health. We previously provided the recommendations below to your VAD clinician team, and we want to make sure you also have this information about our commitment to supporting you:
Medtronic remains committed to supporting patients living with the HVAD System, as well as the caregivers who participate in their care, by continuing to provide resources designed to aid and assist them. MEDTRONIC IS STILL WALKING BESIDE YOU.
There is nothing more important to Medtronic than the safety and well-being of patients. Although we have stopped distribution and sale of the HVAD™ System, we are committed to serving the needs of the approximately 4,000 patients currently implanted with the device globally. (For more information about left ventricular assist devices and the HVAD System, please see the section below.)
In consultation with an independent panel of clinician advisors, we have developed patient management recommendations and a support program for these patients, their caregivers, and the clinicians who participate in their care. The program includes:
Medtronic has been working with the FDA and other global regulators to ensure that patients and their clinicians have information about this patient and provider support program. We are committed to supporting them to ensure they have access to the best available guidance and resources.