Ancora Heart kicked off a European clinical study for its device designed to directly repair an enlarged left ventricle from the inside, as a treatment for patients suffering from heart failure.
The unique transcatheter approach of the AccuCinch system aims to treat the dilation and dysfunction of the left ventricle by placing a cable around the perimeter of the chamber’s interior wall and fastening it in place using a series of anchors.
The cable is then tightened, reducing the volume of the ventricle while supporting the strength and shape of the wall. The goal is to improve overall heart function, as well as reduce functional mitral regurgitation, according to the Santa Clara, California-based company.
The company estimates that about half of patients with heart failure have an enlarged left ventricle, which causes more stress on the heart as it tries to pump blood to the body. As many as 50% of people diagnosed with heart failure die within five years.
By girding the base of the left ventricle, the repair therapy also aims to preserve the natural structure of the mitral valve and leave the patient open to future treatment options.
Ancora has enrolled the first participant in its planned multi-center study, which hopes to register about 130 European patients with reduced ejection fraction systolic heart failure. This is the second clinical test of the AccuCinch system focused specifically on heart failure and an enlarged left ventricle—the company began enrolling patients in a U.S. feasibility study this past May (PDF).
An earlier interim analysis (PDF) of 16 patients with heart failure and functional mitral regurgitation showed no major adverse cardiac events after 30 days, and an average reduction of 29% in the volume of the left ventricle. Ejection fraction measurements improved from 30% to 42%, while regurgitation grades and volumes were reduced.