FDA Grants Breakthrough Device Designation To Ventricular Restoration Device

The FDA has awarded Breakthrough Device Designation to Ancora Heart’s Accucinch ventricular restoration system. The device was constructed to help reduce ejection fraction from patients with symptomatic heart failure. It achieves this by restoring the makeup and activity of an enlarged left ventricle. In turn, heart failure symptoms are reduced and the quality of life of patients is improved greatly. 

The FDA Breakthrough Devices Designation program was introduced to help patients receive timely access to treatment innovations without compromising their safety. The program helps expedite the development of novel medical devices that have the potential to give more effective treatment to patients with severe conditions or diseases.  

In the U.S alone, approximately 6.5 million adults suffer from heart failure. Reduced ejection fraction constitutes roughly half of those with heart failure. Reduced heart fraction can cause a multitude of symptoms including dyspnea, orthopnea, ankle swelling, and fatigue. Current treatment consists of guideline-directed medical therapy, which requires patients to implement lifestyle changes and undergo cardiac resynchronization therapy. However, the current treatment practices are often unsuccessful, as heart failure can progress quickly. Patients resistant to current heart failure treatment must seek a heart transplant, palliative care, or acquire a left ventricle assist device. 

Ancora Heart’s Accucinch ventricular restoration system is currently undergoing evaluation in a clinical trial. The trial will consist of up to 400 patients who receive guideline-directed medical therapy for heart failure. In previous studies, the device has been found to significantly reduce diastolic volumes at 12 months and to significantly improve quality of life for patients. Additionally, the device has shown to improve six-minute walking distances of patients 12 months into care. Ancora Heart has received approximately $80 million as a result to expedite its development. Experts believe the ventricular restoration system has a promising future, with great potential to help improve the lives of heart failure patients.