Fridley, Minn.-baed Medtronic this morning issued a notice to physicians informing them to stop new implants of the HVAD system and to transition to an alternative means of durable mechanical circulatory support, according to a news release.
The company said it is developing a support program for patients who had an HVAD implanted to ensure the ongoing care and safety of such patients, of which there are approximately 4,000.
FDA issued a statement alerting providers to no longer implant the HVAD system for the same reasons laid out by Medtronic. Dr. Bram Zuckerman, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices & Radiological Health, said the FDA is working closely with Medtronic to “ensure patient care is optimized” as the device is taken off the market.
The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons that demonstrates a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available devices, as well as complaints that the internal pump may delay or fail to restart.
Medtronic said the decision came in light of several clinical comparisons indicating a higher frequency of neurological adverse events, including stroke and mortality, with the HVAD system. In February, the company recalled the device after 855 complaints and eight injuries related to an issue with the device’s ports. Medtronic reported 12 deaths among implanted patients in that recall, although three weren’t related to the particular issue at hand.
“The Medtronic mission guides us to always do what is in the best interests of patients, and that is exactly what we are doing and will do for those impacted by this decision. There is nothing more important than the safety and well-being of patients,” president of Medtronic’s mechanical circulatory support business Nnamdi Njoku said in the release. “We recognize this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them in coordination with their physicians.”
In response to Medtronic taking the HVAD off the market, Abbott (NYSE:ABT) issued a statement confirming that it has the capacity to support the growing demand for mechanical circulatory support devices with its HeartMate 3 heart pumps.
Abbott Park, Ill.-based Abbott said it is also supporting training and education programs for additional physicians who will now be offering its HeartMate 3 pumps.
“For years, we have seen truly life-saving results in patients treated with mechanical circulatory support devices. Ensuring continued access to these devices is critical for patients,” SVP of Abbott’s electrophysiology & heart failure business Mike Pederson said in a release. “We are working to ensure that physicians have the support and training they need as they further adopt HeartMate 3 to improve outcomes for their advanced heart failure patients.”
Analysts at Truist said today that they maintain their “Buy” position on Medtronic. While they acknowledged the situation is unfortunate for the company, they don’t anticipate a material negative financial impact on its growth.
Danielle Antalffy and Rebecca Wang at SVB Leerink thought Medtronic made a wise choice: “Overall, we think this business exit is the right move, with MDT not only putting patients first but also cutting an unprofitable product line, from a financial perspective.”
This story was updated with information from the FDA and analysts.
