BioVentrix said today that it enrolled and treated the first patient in its Revive-HF European trial to evaluate the Revivent TC system for the treatment of ischemic cardiomyopathy-induced heart failure.
The patient, who had suffered a heart attack that resulted in left ventricle scarring and ischemic heart failure, was successfully implanted with three anchor pairs at Deutsches Herzzentrum in Berlin.
The European, multi-center, dual-arm randomized controlled study is comparing the Revivent TC system to guideline-directed medical therapy or drug treatment. BioVentrix plans to enroll 180 patients, with 120 of them set to be treated with the Revivent TC system and the remainder to be treated with guideline-directed medical therapy.
BioVentrix said the primary endpoint of the trial will be improvement in heart failure symptoms based on a six-minute walking test. The company estimates a primary completion date of Dec. 31, 2020 and a study completion date of Dec. 31 2022, according to ClinicalTrials.gov.
Revivent TC is designed to exclude scar tissue from healthy tissue on the left ventricle in a procedure that is less invasive than guideline-directed medical therapy or drug treatment. The end result should be decreased systolic volume and increased efficiency in the left ventricle.
“The Revivent TC system for less invasive ventricular remodeling offers patients a treatment option for ischemic heart failure,” primary investigator Dr. Volkmar Falk said in prepared remarks. “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.”
“A critical parameter to survival for these types of patients is cardiac volume,” added Dr. Sebastian Kelle. “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.”
BioVentrix enrolled its first U.S. Revivent TC patient in October 2017. This year, the company pulled in a $22 million funding round in April, followed by an $18 million round in July. In February of this year, BioVentrix said that it won renewed German reimbursement for the Revivent TC system.
