Bioventrix said today it won FDA investigational device exemption approval to initiate a pivotal trial of its Revivent TC transcatheter ventricular enhancement system device designed for reshaping and restoring the left ventricle.
Revivent is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart. Instead, the transcatheter procedure enables placement of small titanium anchors along the heart’s outer surface and along one of the inside walls, according to Bioventrix. The anchors are then pulled toward each another in a way that excludes scarred and non-functioning portions of the heart wall.
“The Revivent TC system has recently demonstrated efficacy in clinical trials performed in the EU. This technology provides a less invasive means for LV scar reduction/exclusion in patients with prior myocardial infarction and LV dysfunction. Restoration of LV morphologic and volume characteristics in a less invasive manner, compared with current surgical ventricular restoration, will ideally avail this technology and procedural concept to a larger patient population,” medical affairs veep Dr. Ryan Brown said in a prepared release.
The trial, which the company has titled Alive, is slated to enroll 120 patients at 20 sites across the U.S. with a planned primary endpoint analysis at 1 year. Endpoints include improvements in ejection fraction, volume reduction, quality of life, New York Heart Association Class, 6-minute walk test and rehospitalization rate.
“Heart failure continues to be an epidemic and the Bioventrix technology fills a critical need here in the U.S. for ischemic patients. The current therapy, surgical ventricular reconstruction, is effective yet it is highly invasive and limited in terms of patients being able to withstand the procedure. This IDE approval provides another treatment option that physicians can consider when exploring the best therapy solution for heart failure patients,” trial principal investigator Dr. Andrew Wechsler said in prepared remarks.
Earlier this month, Bio Ventrix said it successfully implanted its micro-anchor Revivent device into a 64-year-old female patient suffering from heart failure symptoms following a heart attack.
The 1st-in-human test follows a similar successful procedure in a pre-clinical model last December. Researchers used Revivent in what it refers to as LIVE (less-invasive ventricular enhancement) a transcatheter-based procedure designed to reshape and reduce the size of the wall of the heart’s left ventricle.
The company, which is based in San Ramon, Calif., and Vilnius, raised $14 million last December in a new round of equity funding involving 64 anonymous investors.
