Medtronic has gained FDA approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for advanced heart failure patients. The Dublin-based company picked up the technology when it acquired HeartWare in 2016. The firm said the technology is the only LVAD approved in the U.S. for implant via thoracotomy, a small lateral, surgical incision between the patient's ribs on the left side of the chest.
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 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.
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 2018 Scientific Sessions in April.
"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., M.D., professor and director, Heart Transplant & Ventricular Assist Device Program, Loyola University Medical Center, Maywood, Ill., and principal investigator of the LATERAL trial, said in a 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."
The company stumbled a bit with the technology recently. The HeartWare technology faced a Class I recall that included 204,017 devices. However, the firm said the likelihood of the problem causing a serious adverse event in a patient is very low.
Medtronic and Abbott are the two biggest competitors in the LVAD market. The Abbott Park, IL-based company gained access to the market when it picked up St. Jude Medical for $25 billion. St. Jude came into possession of its heart failure technology when it acquired Thoratec for $3.4 billion.
Oddly enough, Thoratec once tried to acquire HeartWare, but backed off because the deal was challenged by the Federal Trade Commission.