June 3, 2021 – Medtronic plc (Dublin, Ireland) announced its stopping the distribution and sale of the Medtronic HVAD System. This morning, the company notified physicians to cease new implants of the HVAD System and transition to an alternative means of durable mechanical circulatory support.
Medtronic also announced that it is developing a support program for patients who have had an HVAD implanted and for caregivers and health care professionals who participate in their care. This program is being developed with an independent panel of clinician advisors to ensure the ongoing care and safety of patients who are currently supported by the HVAD system. Though the company will stop distribution and sale of the HVAD System, Medtronic is committed to serving the needs of the approximately 4,000 HVAD patients currently implanted with the device.
Medtronic says it initiated the action in light of 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.
Medtronic previously issued an Urgent Medical Device Communication informing physicians that the HVAD 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 hospitalization, 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 prioritize patient safety.
Medtronic has been working closely with the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this decision and its commitment to ongoing support for patients implanted with the HVAD device.