HeartWare HVAD system receives US FDA approval

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Medtronic HeartWare HVAD System

Medtronic has received United States Food and Drug Administration (FDA) approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for patients with advanced heart failure. The HVAD System is the smallest commercially available LVAD, and the only LVAD approved in the US for implant via thoracotomy, a small lateral, surgical incision between the patient’s ribs on the left side of the chest.

LVADs help the heart pump and increase the amount of blood that flows through the body. They are typically implanted via median sternotomy, a surgical procedure in which a vertical incision is made down the middle of the chest, after which the sternum (or breastbone) is divided.

FDA approval for HVAD implantation via thoracotomy is based on data from the LATERAL prospective clinical trial, in which 144 patients, with end-stage heart failure who were eligible for heart transplant, were enrolled at 26 centres in the US 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. Since the success outcome exceeded the pre-specified performance goal of 77.5%, the trial achieved its primary endpoint (p=0.0012). The key secondary endpoint revealed a significant reduction in total length of hospital stay, from an average of 26.1 days down to 18 days (p<0.001). Overall survival among patients receiving an HVAD via the thoracotomy procedure was 88.8% at one year. Detailed outcomes of the LATERAL trial and its secondary endpoints were presented at The International Society for Heart and Lung Transplantation (ISHLT) 2018 Scientific Sessions.

“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,” said Edwin McGee, Jr., professor and director, Heart Transplant & Ventricular Assist Device Program, Loyola University Medical Centre, Maywood,USA, and principal investigator of the LATERAL trial. “Implanting the HVAD via thoracotomy preserves the chest for a subsequent procedure that patients may need, such as a heart transplant. It also has been shown to result in shorter hospital stays.”

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