Transcatheter heart failure implant from Ancora Heart linked to positive 2-year data
A transcatheter device designed to reduce the size of the left ventricle in heart failure patients is associated with reverse remodeling that lasts through two years, according to new findings published in Structural Heart.[1]
The AccuCinch System from California-based Ancora Heart is a flexible device that cardiologists attach to the inner wall of the left ventricle. Once implanted, the device reduces the size of the left ventricle, reduces ventricular wall stress and strengthens the heart wall.
For this analysis, researchers tracked 51 symptomatic patients who presented with heart failure with reduced ejection fraction (HFrEF). After two years, sustained reverse remodeling was confirmed, and patients experienced significant improvements in quality of life in terms of Kansas City Cardiomyopathy Questionnaire scores. Patients receiving the implant were also linked to a reduced risk of heart failure hospitalization after two years.
The AccuCinch System previously received the FDA’s breakthrough device designation. Ancora Health is currently recruiting patients for CORCINCH-HF, a clinical trial the company hopes will pave the way for a full FDA approval. The company recently reached a key milestone, recruiting the first 250 patients to participate in CORCINCH-HF. The goal is to recruit 400 patients in total.
“Reverse remodeling is usually associated with reduced heart failure events and mortality,” Daniel Burkhoff, MD, PhD, director of heart failure, hemodynamics and MCS research at the Cardiovascular Research Foundation, said in a prepared statement. “From a clinical perspective, the fact that reverse remodeling is maintained at two years is particularly meaningful.”
“These two-year data reinforce that the AccuCinch System has the potential to deliver meaningful and sustained reverse remodeling of the heart,” added Jeff Closs, president and CEO of Ancora Heart. “We are excited to build on this research in our ongoing CORCINCH-HF pivotal trial designed to evaluate the safety and effectiveness of AccuCinch.”
