BioVentrix said today it enrolled the 1st US patient in a pivotal clinical trial of its Revivent TC transcatheter ventricular enhancement system designed to treat patients with heart failure symptoms related to cardiomyopathy.
The Revivent system is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of small titanium anchors along the heart’s outer surface and along 1 of the inside walls, according to the San Ramon, Calif.-based company.
The 1st US patient was enrolled at the UPMC Heart and Vascular Institute by Dr. Catalin Toma and Dr. Christopher Sciortino, and was successfully implanted with 3 micro-anchor pairs in a patient suffering from ischemic heart failure, the company said.
“UPMC remains at the forefront of implementing promising less invasive therapies to address the need for better heart failure treatment. We are pleased to be the first U.S. center to implant the Revivent TC System as part of the Alive clinical trial. The procedure aims to reshape the left ventricle, decrease the left ventricular end systolic volume index, and increase the ejection fraction. The patient was discharged shortly after the procedure and is recovering well,” Dr. Toma said in a prepared statement.
“The Live procedure is less invasive and less traumatic than conventional surgical reconstruction. It expands the patient population that can be treated by reducing the procedural risk. The patient was able to undergo this procedure without having to perform a sternotomy or employ cardiopulmonary bypass,” Dr. Sciortino said in a press release.
The trial is slated to enroll 120 patients at 20 sites across the US and UK, with a primary endpoint analysis at 1 year. Trial endpoints include positive effects on volume reduction, ejection fraction, quality of life scores, New York Heart Association classes, 6-minute walk test and rehospitalizations.
The 1st patient in the trial was enrolled in late August at the U.K.’s Papworth Hospital, the company reported.