Ancora Heart has announced enrolment of the first patient in a US early feasibility study evaluating the treatment for patients with reduced ejection fraction systolic heart failure (HFrEF) using its AccuCinch Ventricular Repair System.
Hemal Gada, an interventional cardiologist, at the UPMC Pinnacle Harrisburg and Mubashir Mumtaz, the chief of cardiothoracic surgery have enrolled the first patient for the study.
Gada said: “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.”
Ancora Heart said that the present early feasibility study marks the second such study in the US evaluating the safety of AccuCinch system, and is planned to enrol up to 15 patients from heart centres across the country.
In May 2018, Ancora Heart secured the US Food and Drug Administration (FDA) clearance for the expansion of patient enrolment in the initial study evaluating the AccuCinch system in patients with heart failure and functional mitral regurgitation (FMR).
Ancora Heart president and CEO Jeff Closs said: “Enrolling the first patient in this heart failure study is a significant milestone in our mission to profoundly improve the care and quality of life of heart failure patients.
“We believe the preliminary data from our initial AccuCinch feasibility study suggests that repairing the enlarged left ventricle directly may fundamentally improve heart function. We are thrilled to have the opportunity to better understand AccuCinch’s potential benefits in this currently underserved patient population with HFrEF.”
The company said that the two AccuCinch studies are enrolling patients simultaneously and are carried out under the same investigational device exemption approved by the FDA.
Ancora Heart has designed the transcatheter AccuCinch therapy to complement and enhance the existing care provided by the cardiologists in further managing the symptoms and reducing or stopping the progression of heart failure.
In addition, 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 said that AccuCinch could have the potential to reverse the enlargement of the left ventricle in some patients, and in patients with heart failure progressed beyond the ability for medications and pacemakers to manage symptoms, therapy with AccuCinch could provide an effective treatment option.