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# Medtronic Gains OK for Easier HVAD Device Implantation
- URL: https://www.fdaweb.com/medtronic-gains-ok-for-easier-hvad-device-implantation/
- Published: 2018-07-11T12:00:00.000Z
- Updated: 2026-09-15T00:18:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141843

FDA has approved a Medtronic PMA for a less-invasive implant approach for its HVAD System, a left ventricular assist device (LVAD) for patients with advanced heart failure. The device is the only LVAD approved in the U.S. for implant via thoracotomy, a small lateral surgical incision between the ribs on the left side of the chest, according to the company. Approval is based on data from the LATERAL prospective clinical trial where 144 patients, with end-stage heart failure who were eligible for heart transplant, were enrolled at 26 centers in the U.S. and Canada. The primary endpoint of the trial demonstrated non-inferiority of the HVAD implanted in patients via thoracotomy, where survival at six months free from disabling stroke or device explant or exchange due to malfunction was achieved in 88.1% of patients, the company says. “Since the success outcome exceeded the pre-specified performance goal of 77.5%, the trial achieved its primary endpoint (p=0.0012),” it adds.