Left Ventricular Assist Device (LVAD) for Advanced Heart Failure Still Walking Beside You Because Patient Care Still Matters

URGENT PRODUCT UPDATE

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 will provide ongoing product support for the HVAD System and will ensure continued availability of equipment for your device, including items such as batteries, chargers, and replacement controllers needed to support your HVAD pump.
• Continue to follow-up regularly with your VAD Clinical team and follow your health care providers’ advice and directions.
• NEVER disconnect your HVAD pump from two power sources at the same time.  Always have a back-up controller and fully charged spare batteries available.
• Continue to maintain your blood pressure and anti-coagulation (blood thinners) within the range set by your VAD Clinical team to minimise the risk of a stroke.
• Immediately notify your VAD Clinical team if you experience any issues including, but not limited to, any damage to the equipment, high and medium priority alarms, or any alarms that may resolve too quickly to identify, with your HVAD pump and equipment.

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.

Patient and Provider Support Program 

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: 

• Ongoing product support for your HVAD System and continued availability of accessories for your device, called peripherals, including items such as batteries and replacement Controllers needed to power your HVAD Pump.
• Local HVAD-trained clinical support teams, with at least one HVAD-trained clinical specialist in each region globally, to assist the local needs of centers who are supporting HVAD patients. These dedicated team members will provide patient education, device transition assistance (if transition to an alternative LVAD is advised by your physician), driveline maintenance and other technical support, and monitoring and management of HVAD peripherals. These support teams also will continue to assist clinicians with waveform interpretation (visualisation of blood flow taken every 15 minutes) and Autolog use (data management of the waveform logfiles).
• A centralised HVAD technical team, staffed by engineers who provide technical support to clinicians and patients and offer other related VAD services, such as quality analysis and troubleshooting.
• Resources for HVAD patients, including a library of training modules available through the local clinical support teams, an e-newsletter to keep patients and clinicians connected and informed, and a range of education and training materials available on the Medtronic Academy and YouTube.

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.