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The HeartWare system is now off the table for left ventricular assist device (LVAD) candidates with advanced heart failure, the FDA .

Medtronic is halting the global distribution and sale of the HeartWare system following observational evidence associating the LVAD with increased neurological adverse events and mortality compared with similar mechanical circulatory support (MCS) devices.

Some HeartWare LVADs had already been recalled in December 2020 because of complaints that the pump may delay or fail to start. To date, there have been over 100 of these complaints, including reports of 14 patient deaths and 13 cases where an explant was necessary, the FDA noted.

"We have been carefully monitoring the adverse events associated with this device and support its removal from the marketplace," said Bram Zuckerman, MD, director of the Office of Cardiovascular Devices at the FDA's Center for Devices and Radiological Health, in a statement.

In an , Medtronic now advises physicians to immediately stop new implants of the HeartWare device, but does not recommend prophylactic explant of the device.

The company is working on a plan for ongoing support of patients who currently have this LVAD -- approximately 2,000 patients in the U.S. and 4,000 worldwide.

FDA named Abbott's HeartMate 3 as one alternative LVAD for patients with end-stage heart failure.

"The FDA 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," said Zuckerman.

Abbott reassured the public in its own that it has the capacity and supply to support increased demand for MCS devices as a result of HeartWare's departure from clinical use.

HeartWare was first approved for commercial use in the U.S. in November 2012.

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