Medtronic Stops Distribution and Sale of HVAD System

June 3, 2021—Medtronic announced it is stopping the distribution and sale of the Medtronic HVAD system, a left ventricular assist device. The Medtronic HVAD system is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a bridge to cardiac transplantation, myocardial recovery, or as destination therapy in patients for whom subsequent transplantation is not planned.

The company notified physicians to cease new implants of the HVAD system and transition to an alternative means of durable mechanical circulatory support.

Additionally, Medtronic 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 it 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, stated the company in the announcement.

Medtronic advised it has been working closely with the 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. Patients with a HVAD implanted should contact their physician with questions or concerns. More information is available from the company at www.Medtronic.com/HVADsafety.

According to the company’s announcement, Medtronic initiated this 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.

In addition, 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 consulted with an independent panel of clinician advisors to develop patient management recommendations to reduce stroke risk and mitigate against other potential risks associated with the HVAD system. Elective explant of the HVAD device is not recommended, as risks associated with explantation may outweigh the potential benefits.

Medtronic is also developing an ongoing support program for patients who have had an HVAD implanted, caregivers, and health care professionals who participate in their care. The program will include financial assistance for eligible patients and other resources for physicians and their caregivers. Further details of the program will be announced when they become available.

Finally, Medtronic is working closely with other stakeholders including Abbott, which manufactures the HeartMate 3 left ventricular assist device (LVAD), and with regulatory bodies globally, to help ensure that alternative treatment options are available for patients who may be candidates for an LVAD.