Medtronic Withdraws Heart Pump HVAD System From The Market
Medical devices maker Medtronic plc (MDT) will stop the distribution and sale of the Medtronic Heartware Ventricular Assist Device (HVAD) System. It has also notified physicians to cease new implants of the HVAD System and transition to an alternative means of durable mechanical circulatory support such as the Abbott Heartmate 3 Left Ventricular Assist System (LVAS).
Meanwhile, the U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with the HVAD System as it has shown a higher frequency of neurological adverse events and mortality.
In some cases, the internal heart pump HVAD System may delay or fail to restart, which can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death.
This action comes after Medtronic received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was necessary.
According to Medtronic, there are approximately 2,000 patients in the U.S. implanted with the device and 4,000 worldwide.
The HVAD System is a full-support, durable left ventricular assist device (VAD) that helps the heart pump and increases the amount of blood that flows through the body in patients with advanced heart failure. It is a less-invasive thoracotomy approach, destination therapy, and bridge to transplant.
Medtronic has advised patients who have the HVAD System to continue normal use of device components and to contact the company for replacement items, such as controllers, batteries, AC/DC adapters and carrying case.
However, Medtronic added that decisions about removing the HVAD pump should be made on a case-by-case basis, with careful consideration of the patient’s clinical condition and surgical risks.
The FDA is working closely with both Medtronic and Abbott to ensure patient care is optimized during this transition period and is ensuring the adequate supply of devices for end-stage heart failure treatment.
Meanwhile, 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 will ensure the ongoing care and safety of patients who are currently supported by the HVAD system.
Medtronic’s decision to stop the sale and distribution of the HVAD follows the company’s voluntary recall of a subset of the HVAD pumps in December 2020.
The Medtronic HVAD System was first approved for commercial use in the U.S. in November 2012. It is currently approved as a bridge to heart transplantation in patients who are at risk of death from end-stage left ventricular heart failure. Medtronic inherited the HVAD system when it acquired HeartWare for $1.1 billion in 2016.
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