IDE Approved for Trial of Neovasc's Tiara Transcatheter Mitral Valve

October 9, 2014—Neovasc Inc. announced that it has received conditional investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate the United States arm of its TIARA-I early feasibility trial. The TIARA-I is a multinational, multicenter trial being conducted to assess the safety and performance of Neovasc's Tiara transcatheter mitral valve system and implantation procedure in high-risk surgical patients with severe mitral regurgitation (MR). Tiara is a self-expanding mitral bioprosthesis designed for transapical transcatheter mitral valve replacement.

The TIARA-I Early Feasibility trial will enroll up to 30 patients globally and is being overseen by a multidisciplinary committee cochaired by Martin Leon, MD, and Anson Cheung, MD. Dr. Leon is Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital in New York, New York. Dr. Cheung is Professor of Surgery and Director of Cardiac Transplant at St. Paul's Hospital in Vancouver, Canada.

According to the company, this FDA conditional approval allows clinical investigators to begin enrolling patients at participating medical centers in the United States when local hospital and related approvals are in place. TIARA-I is expected to enroll patients at Columbia University Medical Center/New York-Presbyterian Hospital, Lenox Hill Hospital in New York, and Cedars-Sinai Medical Center in Los Angeles, California. The company is training participating clinical teams and obtaining institutional approvals with the goal of enrolling the first United States patients by early 2015.

TIARA-I also has received ethics committee approval at Antwerp Cardiovascular Center/ZNA Middelheim in Belgium and competent authority notification is pending. The first European enrollment is expected before the end of the year. Applications are underway for additional centers in Europe and Canada.

In February 2014, Neovasc announced that the first-in-human implantations of Tiara were performed under Canadian Special Access by the medical team at St. Paul's Hospital. Early clinical results of Tiara implantations have shown fully functional valves, with complete resolution of MR, no valve leakage, and no device-related complications, stated the company.