Ancora Heart today announced two-year results from an analysis of early clinical studies evaluating its AccuCinch system.
Findings evaluating AccuCinch, a transcatheter left ventricular restoration system, were published in Structural Heart. They demonstrate that patients sustained reverse remodeling with AccuCinch through two years. Additionally, findings included improvements in heart function, quality of life and reduced heart failure hospitalizations.
Santa Clara, California-based Ancora Heart said findings build on previously reported 12-month data shared in 2023. That data showed that patients treated with the investigational device saw improvement in heart failure outcomes and beneficial changes in the structure of the heart.
The latest analysis comes from 51 heart failure with reduced ejection fraction (HFrEF) patients across multiple U.S. and European sites. Key outcomes included sustained reverse remodeling, improvements in functional status and symptoms and a significantly reduced rate of heart failure hospitalization at two years post-implant compared to the year prior to implantation.
Ancora Heart plans to enroll 400 patients overall in its CORCINCH-HF trial. Earlier this year, the study achieved its first enrollment milestone of 250 randomized patients. Six-month data from that cohort supports the company’s planned FDA premarket approval (PMA) submission.
AccuCinch already holds FDA breakthrough device designation. The company designed its device to augment the existing care cardiologists provide HF patients. It may provide a new treatment option to fill the gap between medication or pacemaker therapy and left ventricular assist device (LVAD) or heart transplant.
In a minimally invasive procedure, the flexible implant attaches to the inner wall of the left ventricle, then cinches. Ancora Heart designed it to reduce the size of the left ventricle, reduce ventricular wall stress and strengthen the heart wall.
“These two-year data reinforce that the AccuCinch System has the potential to deliver meaningful and sustained reverse remodeling of the heart,” said Jeff Closs, president & 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. With the first 250 enrolled patients nearing completion of their six-month follow-up assessments that will be the basis for our PMA submission, we are making important progress toward bringing this therapy to more patients.”
