Ancora Heart has expanded enrollment of US early feasibility study for the AccuCinch System for left ventricular repair.
The investigational AccuCinch ventricular repair system is designed for the treatment of heart failure and functional mitral regurgitation (FMR).
The company’s move follows approval from the US Food and Drug Administration to enroll a second group of subjects and extend to 15 heart centers across the country.
Ancora Heart president and CEO Jeff Closs said: “We are pleased that the FDA has approved expansion of this study, as it will allow us to continue to gather valuable clinical information about AccuCinch.
“We are encouraged by our early clinical experience and interest from new heart centers to participate in the study.”
The AccuCinch procedure is claimed to directly repair the enlarged left ventricle, which is the underlying cause of heart failure.
The minimally invasive procedure has been designed to reduce the size of the left ventricle, improve left ventricular function and reduce symptoms of heart failure.
Ancora Heart stated that the AccuCinch therapy has the potential to treat heart failure and FMR patients in whom the disease has advanced beyond the situation where medications and pacemakers can manage the symptoms or for whom the risks of open-heart surgery are too high.
The technology of AccuCinch is different from the present technologies which replicate surgical procedures to replace or repair an otherwise normal mitral valve, AccuCinch has been designed to repair the left ventricle directly to enable proper mitral valve function.
About 6.5 million US adults have heart failure, a condition where heart’s muscles slowly weaken and lose their ability to pump enough oxygen-rich blood to the body.
Up to 74% of people with heart failure also suffer from FMR, a condition caused when the left ventricle of the heart becomes enlarged to the point where it pulls the mitral valve leaflets apart and allows blood to flow backwards into the left atrium.
Heart failure and FMR patients suffer from debilitating symptoms such as persistent exhaustion, trouble breathing, confusion and loss of memory. There is no cure for heart failure or FMR and about half of people who develop heart failure die within five years of diagnosis.