FDA approves less-invasive LVAD implant procedure

The FDA has cleared a less-invasive implant approach for Medtronic’s HeartWare HVAD system, allowing the left ventricular assist device (LVAD) to be placed through a small incision between the ribs. It is the first LVAD approved in the U.S. to be inserted with this technique, according to Medtronic.

The thoracotomy route was validated in the LATERAL prospective clinical trial, which included 144 patients with end-stage heart failure who were eligible for a transplant. Six-month survival free of disabling stroke or device malfunction requiring removal was 88.1 percent with thoracotomy, exceeding the prespecified goal of 77.5 percent.

Overall one-year survival in patients receiving an HVAD via thoracotomy was 88.8 percent, and average hospital stays were reduced from 26.1 days to 18 days using the less-invasive approach.

"We have demonstrated that a thoracotomy is a safe and effective implant technique for the HVAD System, which gives physicians added flexibility in treating a broad range of patients," Edwin McGee Jr., MD, the principal investigator of the LATERAL trial, said in a press release. "Implanting the HVAD via thoracotomy preserves the chest for a subsequent procedure that patients may need, such as a heart transplant.”

The LVAD is approved in the U.S. and Europe as both a bridge-to-transplant option and a destination therapy for patients who don’t plan to undergo heart transplantation. Surgical implant tools designed for the thoracotomy procedure are also available in America and CE mark countries, Medtronic said.