June 30, 2020
IDE Approved for Pivotal Study of Ancora Heart's AccuCinch Ventricular Restoration System
June 30, 2020—Ancora Heart, Inc. announced FDA approval of its investigational device exemption (IDE) application for the CorCinch-HF pivotal study, which is designed to evaluate the safety and efficacy of the company's AccuCinch ventricular restoration system in patients with heart failure and reduced ejection fraction.
According to the company, the transcatheter AccuCinch system is a completely percutaneous device designed to directly reshape the left ventricle of the heart, thereby addressing the fundamental issue in the progression of systolic heart failure.
The CorCinch-HF pivotal study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch system. The study is designed to enroll 400 patients at up to 80 centers worldwide.
The study design will allow an initial analysis of safety and clinical efficacy for a premarket approval submission after the first 250 patients have reached 6 months of follow-up, and then a second analysis after the entire cohort has reached 12 months of follow-up. The study will ultimately follow patients through 5 years to track long-term results.
Martin B. Leon, MD, is chairman of the CorCinch-HF study. Ulrich Jorde, MD, and Mark Reisman, MD, are coprincipal investigators.
“Patients with heart failure are in need of improved solutions and the AccuCinch technology is unique as it addresses heart function from the perspective of ventricular reshaping, with a minimally invasive approach, and potentially at an earlier phase before progression to advanced disease,” commented Dr. Leon in the company's press release. “The CorCinch clinical programs are developing a new class of therapy and the clinical trials have embraced a strong collaboration between heart failure and structural heart teams. We are encouraged by the clinical benefits demonstrated in the CorCinch feasibility phase and are looking forward to the CorCinch-HF randomized study to confirm these findings.”