FDA Approves HeartWare HVAD System for Implant via Thoracotomy, Median Sternotomy

Medtronic announced the approval by the US Food and Drug Administration (FDA) for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD), for patients with advanced heart failure.

The approval for HVAD implantation via thoracotomy is based on data from the LATERAL prospective clinical trial where 144 patients with end-stage heart failure eligible for heart transplant were enrolled at 26 centers in the US and Canada.

“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, principal investigator of the LATERAL trial, professor and director, Heart Transplant and Ventricular Assist Device Program, Loyola University Medical Center, said in a statement. “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.”

The trial met its primary endpoint of non-inferiority as data indicated an 88.1% rate of survival at 6 months free from disabling stroke or device explant or exchange due to malfunction. Being as the success outcome exceeded the pre-specific performance goal of 77.5%, the trial achieved its primary endpoint ( P = 0.0012).

The key secondary endpoint revealed a reduction in hospital stay length, which decreased from an average of 26.1 days to 18 days ( P < 0.001).

Medtronic said that at 1-year, overall survival among those receiving HVAD via the thoracotomy procedure was 88.8%.

The HVAD system is the only LVAD approved in the US for implant via thoracotomy and median sternotomy, and is approved to treat those with advanced, refractory heart failure as a bridge to cardiac transplantation and as a destination therapy in patients where subsequent transplantation is not planned.

Along with the approval, Medtronic released new surgical implant tools, now available in the US and CE Marked countries, tailored to assist with the thoracotomy approach for the HVAD System.