Myocor receives approval for heart device study

The single-arm feasibility study is designed to evaluate the safety and feasibility of the percutaneously implanted iCoapsys system in treating patients with mitral valve insufficiency caused by left ventricular dysfunction and coronary artery disease.

The first Coapsys device is currently being evaluated in the Restor-MV trial. The iCoapsys device and implant procedure based on the original, surgically implanted Coapsys system is said to reduce functional mitral regurgitation and reshape the left ventricle to provide a more complete reshaping therapy than traditional mitral valve repair. The development of the iCoapsys system will allow Myocor to provide physicians with both surgical and percutaneous options for their patients.

Wes Pedersen, interventional director, complex valve disorders, at the Minneapolis Heart Institute, said: “The iCoapsys system offers patients an innovative, less invasive option for treating their functional mitral regurgitation.”