Medtronic Halts Heart Failure Device Sales as Risks Surface
(Bloomberg) -- Medtronic Plc is halting sales of its HVAD device that helps patients with advanced heart failure pump blood on growing evidence that it leads to more strokes and other adverse events than competing models.
“The company notified physicians to cease new implants of the HVAD system and transition to an alternative means of durable mechanical circulatory support,” Dublin-based Medtronic said Thursday in a statement. The shares fell as much as 1.2% as of 9:53 a.m. in New York.
Medtronic is developing a program with an independent panel of clinician advisers to support the approximately 4,000 patients who currently have the device implanted. The company said it previously warned physicians that the HVAD pump may experience a delay or fail to restart after it’s stopped, which can worsen a patient’s heart condition and even result in death.
Abbott Laboratories said in a statement that it has capacity and supply to support increased demand for HeartMate 3 devices that it makes. Abbott said it’s working with doctors to make sure they have the support and training to use the device.
The Food and Drug Administration “is working closely with both Medtronic and Abbott to ensure patient care is optimized during this transition period and that there is an adequate supply of devices available to provide this patient population with options for end-stage heart failure treatment,” Bram Zuckerman, director of the FDA’s Office of Cardiovascular Devices in the Center for Devices and Radiological Health, said in a statement.
Medtronic’s HVAD system has been implanted in more than 19,000 patients worldwide over the past 10 years, according to the company website. The company recalled the HVAD pump implant kit in March because of failures to initially start or restart, or because it could have a delay in restarting after the pump was stopped.
In April, the company recalled the device’s battery cables, adapter cables and controller ports because wear and tear could cause damage that might lead to a full or partial stop of the pump. In May, Medtronic recalled the device’s instructions for use and manual to update information about a number of issues.
Abbott Device Safety
In December 2020, Medtronic warned physicians of an issue where the HVAD pump may experience a delay to restart or a failure to restart. The company still has not been able to pinpoint a root cause for the failures, Kathleen Janasz, a spokeswoman, said in an email.
The decision to halt sales of the device “is solely driven by patient safety, which is our foremost priority,” Janasz said. A growing body of evidence show that Abbott’s HeartMate 3 is associated with a lower rate of neurological adverse events and deaths compared to the HVAD, she said.
Revenue from the HVAD system and associated accessories was $141 million in fiscal 2021, the company said. Medtronic expects the move to be neutral to slightly accretive to fiscal 2022 adjusted earnings per share. The potential loss of HVAD revenue was contemplated in the company forecast issued May 27, according to the statement.
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