Dec 20, 2021

Medtronic Statement – HVAD Communication Update, Dec. 20, 2021

The wellbeing of patients, and their experiences with our technologies, are core to our mission. This is why we’ve set up support programs, services, and feedback mechanisms for patients with the HVAD™ System. Although we stopped distribution in June 2021, we continue to monitor the performance of the HVAD System. We provide up-to-date information and guidance from independent clinical experts as available, so patients and their care teams can make the most informed treatment decisions.

Patients with the HVAD System are seriously ill and need assistance so their hearts can continue to pump the blood necessary to sustain life. Since its approval, the benefit/risk profile and value of the HVAD System for these patients were significant. Lives were saved and others extended with the device at a time when other treatment options were limited or nonexistent. All our HVAD System decisions over the years have been based on the available clinical information. Once it became clear in June 2021 that a better patient treatment option was available, we decided it was in the best interest of patients to discontinue distribution of the HVAD System.

We’re committed to helping ensure patients with the HVAD System have the clinical and financial support needed achieve the best possible outcomes. We encourage all patients and their care teams with questions to visit our website (www.medtronic.com/us-en/patients/treatments-therapies/ventricular-assist-device.html) or contact us through the dedicated patient hotline at 1-800-635-3930.