World Heart, a developer of mechanical circulatory systems, has reported that the first US implant of the Levacor Ventricular Assist Device (VAD) has been performed at Integris Baptist Medical Center (Integris) in Oklahoma City.
The company claims that this is the first implant in the Levacor VAD bridge-to-transplant (BTT) study, which is expected to enroll 160 patients, pursuant to a recently approved US Investigational Device Exemption Application. Integris is the first of the initial ten BTT clinical study sites.
The recipient, an Oklahoma native, is a 59- year-old woman suffering from severe cardiomyopathy, or a weakened heart muscle, said the company.
Craig Elkins, cardiac surgeon and surgical principal investigator for the study at Integris, said: “The device implant was remarkably smooth with a relatively short procedure and the patient is recovering quickly from her surgery. We are excited to participate in the study and pleased to offer to our patients this new technology.”
Alex Martin, president and chief executive officer of WorldHeart, said: “We are especially pleased to reach this important milestone and are gratified to provide this therapy to bridge those waiting for a donor heart.”