October 16, 2014 - Neovasc Inc. has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the U.S. arm of its Tiara-I Early Feasibility Trial for the company's Tiara transcatheter mitral valve.
The Tiara-I Early Feasibility Trial is a multinational, multicenter trial being conducted to assess the safety and performance of Neovasc's Tiara mitral valve system and implantation procedure in high-risk surgical patients suffering from severe mitral regurgitation (MR).
Severe MR is a critical condition that affects millions of patients and if left untreated, can lead to heart failure or death. This FDA conditional approval allows clinical investigators to begin enrolling patients at participating U.S. medical centers once local hospital and related approvals are in place.
The Tiara-I Early Feasibility Trial will enroll up to 30 patients globally and is being overseen by a multidisciplinary committee of internationally recognized physicians co-chaired by Martin Leon, M.D., (director of Center for interventional vascular therapy Columbia University Medical Center/New York-Presbyterian Hospital) and Anson Cheung, M.D., (professor of surgery and director of cardiac transplant at St. Paul's Hospital, Vancouver Canada).
With FDA approval, Tiara-I expects to enroll patients at three highly respected U.S. medical centers: Columbia University Medical Center / New York-Presbyterian Hospital (New York), Lenox Hill Hospital (New York) and Cedars-Sinai Medical Center (Los Angeles). The Company is focusing on training participating clinical teams and obtaining institutional approvals with the goal of enrolling the first U.S. 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. First European enrollment is expected before the end of the year.
Applications are underway for additional centers in Europe and Canada.
For more information: www.neovasc.com