Early Feasibility Study Begins for Ancora Heart's AccuCinch Transcatheter Heart Failure Therapy
June 3, 2019—Ancora Heart, Inc. announced the first patient was enrolled in a United States early feasibility study evaluating the company's AccuCinch ventricular repair system as a treatment for patients with reduced ejection fraction systolic heart failure.
According to the company, the AccuCinch system is designed to repair the left ventricle of the heart directly, thereby addressing the fundamental issue in the progression of systolic heart failure.
Ancora Heart's transcatheter AccuCinch therapy is designed to complement and enhance the existing care that cardiologists provide to further manage symptoms and slow, or stop, the progression of heart failure. For some patients, AccuCinch may have the potential to reverse the enlargement of the left ventricle. For patients where heart failure has progressed beyond the ability for medications and pacemakers to manage symptoms, nonsurgical percutaneous device therapy with AccuCinch may provide an effective treatment option, stated the company.
The study will enroll up to 15 patients from heart centers across the country. The first patient was enrolled at UPMC Pinnacle Harrisburg in Harrisburg, Pennsylvania, by interventional cardiologist Hemal Gada, MD, Medical Director of the Structural Heart Program, and Mubashir Mumtaz, MD, Chief of Cardiothoracic Surgery and Surgical Director of Structural Heart.
In Ancora Heart's announcement, Dr. Gada stated, “We are pleased to participate in this study because it is the first in the world to evaluate a transcatheter therapy for heart failure that seeks to restore quality of life and longevity by directly improving left ventricular heart function.”
The company noted that this is the second United States early feasibility study evaluating the safety of the AccuCinch system. In May 2018, Ancora Heart announced that the FDA allowed the expansion of patient enrollment in the initial study evaluating the AccuCinch system in patients with heart failure and functional mitral regurgitation.
These two AccuCinch studies are enrolling patients simultaneously and are being conducted under the same investigational device exemption approved by the FDA.