According to results published in the European Journal of Cardio-Thoracic Surgery, 39.6% of the first 11 patients implanted with BioVentrix’s Myocardial Anchoring System had a sustained improvement in heart function at one year.
A press release reported that the patients sustained a mean reduction in left ventricular end-systolic volume index to 43.9 mL/m2, which is below the 60mL/m2 threshold recently defined as providing a survival benefit in heart failure patients. BioVentrix also announced that the number of heart failure centers trained to perform the LIVE procedure has expanded to 20 leading centers throughout Western Europe.
“The extent of volume reduction achieved, and more importantly maintained at one year, using the Revivent System is comparable with, and in some cases exceeds, the results achieved in multiple clinical studies using a conventional surgical approach to reducing the volume of the left ventricle,” said Andrew S. Wechsler, professor of Cardiothoracic Surgery at Drexel University College of Medicine in Philadelphia, Penn, USA. “These results demonstrate that effective volume reduction, using a less invasive approach, provides meaningful clinical benefit to a previously untreated, fragile patient population.”
Since submission of data from the first 11-patients to EJCTS, an additional 15 patients have reached the crucial one-year survival mark. Combined these 26 patients treated with the Revivent System have maintained a mean left ventricular end-systolic volume index of 57.4mL/m2 for one year following the procedure, which represents a mean decrease of 33.5%.
According to the press release, the Revivent System is uniquely designed to reduce wall tension by directly reducing the left ventricular radius, which in turn decreases wall tension and interrupts the ongoing destructive process of ischemic heart failure.
Phase I clinical trials, which led to the CE mark in November 2012, using the Revivent System were conducted at four European sites. A second broader phase now underway has brought system training to 20 additional sites, including several prominent heart failure centers in Germany and Italy.