Myocor Receives Approval For Percutaneous Trial
FDA has granted conditional approval of the Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) feasibility study of Myocor.
The single-arm feasibility study will 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 (CAD).
"Percutaneous valve repair is a new frontier of patient care," said Dr. Wes Pedersen, interventional director, complex valve disorders, at the Minneapolis Heart Institute. "The iCoapsys system offers patients an innovative, less invasive option for treating their functional mitral regurgitation (FMR). It is very exciting to be able to participate in the VIVID feasibility study as the principal investigator at Abbott Northwestern Hospital."
The iCoapsys device and implant procedure are based on the original, surgically implanted Coapsys system. The first Coapsys device is currently being evaluated in the RESTOR-MV trial. Both devices are designed 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.
Initiation of the VIVID feasibility study is another significant milestone for Myocor, a privately held company. Since 1996, Myocor has developed a substantial portfolio of intellectual property related to mitral valve and left ventricle reshaping. "We have been very disciplined in bringing these devices through the design, manufacturing and trial processes with an eye on long-term success," said Myocor CEO, Jim Hickey. "We have been fortunate to have the experience of implanting over 120 Coapsys devices worldwide, the dedication of a talented group of employees and clinicians who believe in our therapy, and the backing of a strong investor group."