BioVentrix said today it launched its Revivent TC transcatheter ventricular enhancement system in China, and that the device has been used in its 1st commercial procedure in the region.
The Revivent system 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 anchors are then pulled toward each another in a way that excludes scarred and non-functioning portions of the heart wall.
“We are very excited to be the first center in China to perform the Revivent TC procedure. The patient achieved a 35% reduction in LVESVI and the ejection fraction increased from 25% to 37%. This was a very positive clinical outcome for this patient which will lead to significant improvement in his quality of life. The Revivent TransCatheter delivery system allows for more ischemic heart failure patients to be treated and reduces the procedural risk compared to other therapy options such as surgical ventricular restoration. We have numerous patients that can benefit from this innovative therapeutic option,” Dr. Yan Wang, who performed the 1st procedure with the devic eat the Xiamen Cardiovascular Hospital, said in a press release.
BioVentrix said it has recently begun enrolling patients in an FDA-approved pivotal clinical trial of the device as it seeks clearance in the US.
Last month, BioVentrix said its Revivent TC won NUB 1 reimbursement status from the German Institute for the Hospital Remuneration System.
This status is the highest of 4 levels, which will bring in full reimbursement for the company at participating hospitals. Payers at these hospitals will be required to cover the gaps in treatment costs for the Revivent system.