FDA Approves HeartWare LVAD for Implant via Thoracotomy

Megan Brooks

Disclosures

July 11, 2018

The US Food and Drug Administration (FDA) has approved Medtronic's HeartWare ventricular assist device (HVAD) for implantation via thoracotomy in patients with advanced heart failure, the company has announced.

Medtronic's HVAD System is the only left ventricular assist device (LVAD) approved in the United States for implant via thoracotomy, the company said. The system is the smallest commercially available LVAD and is already approved for implant via median sternotomy.

In approving the less invasive implant approach, the FDA reviewed data from the LATERAL trial, which enrolled 144 patients with end-stage heart failure who were eligible for heart transplant at 26 centers in the United States and Canada. 

In the trial, survival at 6 months free from disabling stroke or device explant or exchange due to malfunction was achieved in 88.1% of patients implanted with the HeartWare HVAD via thoracotomy. "Since the success outcome exceeded the prespecified performance goal of 77.5%, the trial achieved its primary endpoint (P = .0012)," the company said.

Overall survival among patients receiving an HVAD via thoracotomy was 88.8% at 12 months. Further, a 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 < .001). 

"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, MD, principal investigator of the LATERAL trial, in the news release.

"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," added McGee, professor and director, Heart Transplant & Ventricular Assist Device Program, Loyola University Medical Center, Maywood, Illinois.

"The thoracotomy approach showed significant improvements in patients' quality of life and functional capacity, supported by strong safety and effectiveness data from the study," David Steinhaus, MD, vice president and general manager of Medtronic's heart failure division, said in the release.

The HVAD System is the only LVAD approved in the United States and Europe for implant via thoracotomy as well as a median sternotomy. It is approved to treat patients with advanced, refractory heart failure as a bridge to cardiac transplantation and as destination therapy in patients for whom subsequent transplantation is not planned.

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