Ancora Heart said today that the first patient was enrolled in a European multi-center clinical evaluation of its AccuCinch ventricular repair system intended for treating patients with reduced ejection fraction systolic heart failure.
The first patient was enrolled at Homolka Hospital in Prague, Czech Republic, by Dr. Petr Neužil, head of the hospital’s cardiology department and principal investigator of the study. Co-lead investigator Dr. Vivek Reddy, director of cardiac arrhythmia services at The Mount Sinai Hospital in New York, completed the procedure with Neužil.
“The transcatheter AccuCinch therapy is unique in its ventricular approach, which is intended to improve heart function by repairing the left ventricle for patients with systolic heart failure regardless of its origin,” Neužil said in a news release. “We are pleased to participate in this study because the AccuCinch has the potential to address the shortcomings of current medical, surgical and transcatheter treatments and restore quality of life and longevity for this large patient population.”
This is the second recently initiated study launched by Santa Clara, Calif.-based Ancora study evaluating the AccuCinch system focused specifically on heart failure and the enlarged left ventricle. The study will enroll up to 132 patients from heart centers across Europe.
“AccuCinch promises to be an unprecedented method for improving the care and quality of life for patients with heart failure,” said Ancora Heart president & CEO Jeff Closs. “Enrolling the first systolic heart failure patient in this European study is an important achievement toward our goal of demonstrating that the therapy has the potential to fundamentally improve heart function. This study will provide us with valuable data on the therapy’s potential benefits.”
The AccuCinch ventricular repair system is an investigative device designed for the minimally invasive treatment of heart failure and functional mitral regurgitation. The system is designed to reduce the size of the left ventricle to improve left ventricular function and reduce the symptoms of heart failure, the company said.