FDA granted breakthrough device designation to BioVentrix's heart failure technology, the company said Tuesday.
The device is designed to improve cardiac function after a heart attack by excluding scar tissue on the left ventricle.
BioVentrix is enrolling 120 subjects in a clinical trial to gather data to support a filing to bring the product to market in the U.S.
Surgical ventricular reconstruction is performed in some patients to repair damage caused by heart attacks. By reshaping the heart to counter scarring related to the heart attack, the heart's pumping ability and chest pain symptoms may improve.
But the procedure is a major undertaking. Surgeons place the patient on a heart lung machine and open up their heart.
San Ramon, California-based BioVentrix wants to provide a minimally invasive alternative to the established procedure. The new approach is enabled by the Revivent TC Transcatheter Ventricular Enhancement System, a technology that closes off the damaged part of the left ventricle, thereby reducing the volume of the chamber and otherwise remodeling it in ways associated with improved health outcomes.
European authorities granted a CE mark to Revivent in 2016. European physicians have subsequently published a series of papers on the safety and effectiveness of the device and the minimally invasive procedure it enables.
In August, physicians published two-year data on 89 patients treated with Revivent in the Journal of Cardiac Failure. The study linked the device to statistically significant improvements in the volume of blood pumped out of the left ventricle, a quality of life measure and the distance patients can walk in six minutes. Almost 90% of patients survived past two years.
The physicians said the minimally invasive procedure results in "comparable efficacy to conventional surgical ventricular reconstruction," although the trial lacked a control arm to enable a direct comparison.
BioVentrix is working to generate more evidence to support marketing of Revivent in the U.S. The company designed a 120-subject study comparing Revivent to guideline-directed medical therapy for heart failure, underway at 20 U.S. sites.
The breakthrough designation could help BioVentrix work toward its goal of FDA authorization by enabling it to receive additional input from the agency and an expedited review. Recent changes to the program mean BioVentrix is also in line to benefit from a revised CMS reimbursement process.