BioVentrix said today it received FDA investigational device exemption approval and launched a safety and efficacy trial of its Revivent TC transcatheter ventricular enhancement system designed to treat patients suffering from ischemic 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 one of the inside walls, according to the San Ramon, Calif.-based company.
The San Ramon, Calif.-based company said it enrolled the 1st patient in the Alive trial, with the 1st procedure being performed by Dr. Steven Tsui and Dr. Michael O’Sullivan at the U.K.’s Papworth Hospital. The procedure reshaped the left ventricle through the placement of 3 micro-anchor pairs, aiming to decrease the left ventricular end systolic volume index to increase ejection fraction.
“We are pleased to be the 1st center to implant the Revivent TC System as part of the Alive clinical trial. Before the LIVE procedure, this patient’s quality of life was severely limited by his heart failure. His treatment options were very limited because of his condition. We hope to provide him with significant clinical benefits by performing this novel procedure which is less invasive and less traumatic than conventional surgical reconstruction,” Dr. Tsui said in a prepared statement.
The company plans to enroll a total of 120 patients at up to 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 transcatheter delivery system allows for more ischemic heart failure patients to be treated with reduced procedural risk relative to conventional surgery. Most importantly, this procedure enabled us to achieve a considerable amount of LV volume reduction without the need for open heart surgery or cardiopulmonary bypass,” Dr. O’Sullivan said in a prepared release.
In May, BioVentrix said its Revivent TC transcatheter ventricular enhancement system saw its 1st clinical use in treating ischemic cardiomyopathy at Berlin, Germany’s Deutsches Herzzentrum.
