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Research News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Myocor: FDA has conditionally approved Myocor's plan for a feasibility study of its iCoapsys minimally invasive mitral valve repair system, the firm announced Dec. 4. The single-arm Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) study will evaluate the device in patients with mitral valve insufficiency caused by left ventricular dysfunction and coronary artery disease. iCoapsys is a high-strength cord, anchored by pads on the outside of the heart, which stretches across the left ventricle to pull the sides of the ventricle together and decrease the distance between the mitral valve leaflets. The device can be delivered with interventional catheters through the pericardium. It is the surgically implanted version of the Coapsys that Myocor is evaluating in the Randomized Evaluation of a Surgical Treatment for Off-pump Repair of the Mitral Valve (RESTOR-MV) trial. RESTOR-MV compares Coapsys to annuloplasty repair in patients undergoing coronary artery bypass surgery who also have functional mitral regurgitation (1"The Gray Sheet" Jan. 3, 2005, p. 17)

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