February 3, 2020
Expansion of Ancora Heart’s CorCinch HFrEF Early Feasibility Study Approved by FDA
February 3, 2020—Ancora Heart, Inc. announced that the FDA has approved an expansion of enrollment in the company's early feasibility study (EFS) evaluating the AccuCinch ventricular repair system in patients with reduced ejection fraction heart failure (HFrEF). The approval for expansion allows Ancora Heart to double patient enrollment from 15 to 30 patients and add 10 institutions for a total of 25 in the CorCinch HFrEF EFS.
Ulrich Jorde, MD, and Azeem Latib, MD, are Coprincipal Investigators of the CorCinch HFrEF study. Dr. Jorde is Section Head of Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support at Montefiore Medical Center in New York, New York. Dr. Latib is Medical Director of Structural Heart Interventions at Montefiore Medical Center.
In the company's press release, Dr. Jorde commented, “Because heart failure is a progressive disease, medication therapy can become less effective over time, leaving patients with few treatment options as their condition worsens. The data we have gathered so far indicates that the AccuCinch System has the potential to fill this gap in treatment options which, if validated in the pivotal study, would be of great benefit to patients with heart failure."
Dr. Latib added, “The AccuCinch device is designed to provide structural support to the heart wall so it maintains its ability to pump blood in an efficient manner, providing patients with a new option for improving heart function. My experience to date with the AccuCinch system has been very positive and I’m excited to continue to build on this progress via this and other clinical studies.”
According to Ancora Heart, the transcatheter AccuCinch system is designed to directly repair the left ventricle of the heart, thereby addressing the fundamental issue in the progression of systolic heart failure. The procedure is intended to complement and enhance the existing care cardiologists provide to further manage symptoms and slow, or stop, the progression of heart failure. For some patients, the AccuCinch procedure may have the potential to reverse the enlargement of the left ventricle. For patients in whom heart failure has progressed beyond the ability of medications and pacemakers to manage symptoms, minimally invasive percutaneous device therapy with the AccuCinch system may provide an effective treatment option.