BioVentrix announces first patient treated in ALIVE pivotal Clinical Trial
BioVentrix announced successful treatment of the first patient at the Cardiovascular Institute of the South in the ALIVE pivotal clinical trial. The trial is designed to demonstrate the safety and effectiveness of the Revivent TC TransCatheter Ventricular Enhancement System; a hybrid closed-chest procedure to treat patients suffering from heart failure symptoms related to cardiomyopathy.
The Less Invasive Ventricular Enhancement or LIVE procedure was performed at Terrebonne General Medical Center in Houma, LA by interventional cardiologist Dr. Peter Fail and cardiothoracic surgeon Dr. Donald Netherland. The device was successfully implanted with three anchor pairs in a 58-year-old male patient who suffered a heart attack which resulted in scarring and subsequently developed ischemic heart failure.
Dr. Fail said “The Revivent TC System, as a less-invasive therapy, is a viable solution for patients who suffer from ischemic heart failure. It may provide relief for their symptoms by immediately reducing the volume of their abnormally-dilated heart and also by increasing their ejection fraction. There is no other device on the market that can achieve these significant clinical improvements within a matter of hours. We are very pleased with our first case experience and look forward to being a leader for this technology in the U.S.”
The ALIVE trial plans to enroll 120 patients at up to 20 sites in the U.S. with a primary endpoint analysis at 1 year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life (QOL), New York Heart Association (NYHA) Class, 6 minute walk test, and rehospitalization. Readmission rates following heart failure hospitalization remain high using standard therapies, with ≥ 50% of patients readmitted to the hospital within 6 months of discharge. Left Ventricular volume reduction has been shown to significantly impact short and long-term survival rates.