SAN RAMON, Calif., Oct. 8, 2019 /PRNewswire/ -- BioVentrix, Inc. announced the first patient was enrolled and treated in the REVIVE-HF European study, a prospective multi-center, dual-arm randomized controlled study evaluating the treatment of ischemic cardiomyopathy induced heart failure with the Revivent TCTM System compared to Guideline-Directed Medical Therapy (GDMT) or drug treatment.
The patient was treated at Deutsches Herzzentrum Berlin (DHZB), Germany and was successfully implanted with three anchor pairs in a patient who suffered a heart attack resulting in scarring in the left ventricle and subsequently developed ischemic heart failure.
Principal investigator for REVIVE-HF, Prof. Volkmar Falk (DHZB), said the enrollment marks a significant milestone validating the Revivent TCTM TransCatheter Ventricular Enhancement System to become an important treatment option for ischemic heart failure with reduced ejection fraction (HFrEF) patients.
"The Revivent TC System for less invasive ventricular remodeling offers patients a treatment option for ischemic heart failure," says Prof. Falk. "We lead this trial in Europe as the Revivent TC System has the ability to address the underlying cause of heart failure in heart attack victims, the ventricle. The device can provide substantial volume reduction and exclusion of scar tissue to help remodel the ventricle to become more efficient."
The Revivent TC System offers patients with abnormally dilated hearts the benefits of reducing the dilated heart by less invasively excluding scar (dead tissue) from the healthy tissue on the left ventricle with its anchoring technology. The result is decreased systolic volume providing increased efficiency of the left ventricle.
"A critical parameter to survival for these types of patients is cardiac volume," says Prof. Sebastian Kelle, Cardiologist at DHZB. "We were able to see an immediate impact of around 40% volume reduction resulting in an 36% to 43% increase in ejection fraction for the patient that was treated in the REVIVE-HF trial. We have seen from our previous commercial experience in the last two years that these types of numbers have significantly changed the quality of life of patients who suffer from ischemic left ventricular dysfunction. We are proud to be the first center to enroll in this study."
The REVIVE-HF RCT (NCT03845127) plans to enroll 180 patients with 120 patients to be treated with the Revivent TC System and 60 patients will be maintained on GDMT. Its primary endpoint is improvement in heart failure symptoms based on a 6 Minute Walking Test. The Revivent TC System is intended for use in patients who have had a myocardial infarction (MI) (heart attack), creating a left ventricular scar, resulting in an enlarged left ventricle causing heart failure symptoms. These symptoms include fatigue, shortness of breath and/or physical limitations despite ongoing treatment.
BioVentrix is a privately held medical device company headquartered in San Ramon, CA, USA. Our mission is to improve and expand the treatment available for congestive heart failure (CHF) caused by ischemic cardiomyopathy, through the development of less invasive, catheter-based approaches.
Less Invasive Ventricular Enhancement or the LIVE ™ procedure uses the Revivent TC™ Transcatheter Ventricular Enhancement System to exclude the scar tissue on the left ventricle that has occurred from a heart attack. This is achieved by implanting anchor pairs on the scar along the septum of the right ventricle and outer surface of the left ventricle. Excluding the scar tissue allows the remaining functional healthy tissue of the left ventricle to operate more efficiently. The implant will help remodel the heart back to a more regular shape and size resulting in an improvement in blood flow throughout the body and benefit the rest of the organs.
Note: The Revivent TCTM System is approved for sale in Europe; it is not approved for sale in the United States, but a licensing study is ongoing.
SOURCE BioVentrix, Inc.