Bioventrix said today it won CE Mark approval in the European Union for its Revivent TC transcatheter ventricular enhancement system designed to treat the left ventricle following a myocardial infarction or heart attack.
The Revivent 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 Bioventrix. The anchors are then pulled toward each another in a way that excludes scarred and non-functioning portions of the heart wall.
“The certification for CE marking is not only an important milestone for the company, but also for those who treat heart failure. More importantly, it transforms the spectrum of treatment by offering a minimally invasive therapeutic solution for the previously ignored ventricle. By making this critical treatment available, we are giving physicians an important additional resource that they can utilize in conjunction with existing valvular and vascular therapies, making Guideline-Directed Medical Therapy even more effective. Moreover, it provides access to efficacious and tolerable therapy to many frail patients who previously would have no options. More than 100,000 patients will become eligible each year for this device implant,” CEO Kenneth Miller said in a press release.
Data from a 2-year follow-up study indicated quality of life improvements of 38% in patients treated with the Revivent, as well as a 31% reduction in LV end-systolic volume index and 23% improvement in LV ejection fraction, the company said.
“Heart failure remains an epidemic worldwide and the CE marking certification validates the need for a novel therapy for heart failure patients suffering from left ventricular dysfunction. There is no doubt that LV volume reduction is an important therapy as it directly impacts the parameters that determine prognosis and survival, such as LV volume and ejection fraction. The impact of the Revivent TC System is achieved by transcatheter access to exclude the ischemic portion of the left ventricle from the healthy tissue. This empowers heart teams in Europe, who currently have a backlog of patients, and soon, in the US, to ensure optimal clinical outcomes by minimizing the risk compared to conventional surgery,” CMO Dr. Lon Annes said in prepared remarks.
In May, BioVentrix said it won FDA investigational device exemption approval to initiate a pivotal trial of its Revivent TC transcatheter ventricular enhancement system.
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.
Earlier in May, 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.