Date: 2014-10-09
Type of information: Clinical trial autorization
phase:
Announcement: clinical trial authorisation
Company: OPKO Health (USA - FL) Neovasc (Canada)
Product: Tiara™ transcatheter mitral valve
Action
mechanism: Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Tiara is implanted in the heart using a minimally invasive, transapical transcatheter approach and is designed to replace the diseased native mitral valve without the need for open-heart surgery or use of a cardiac bypass machine.
Disease:
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: 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 Dr. Martin Leon (Director, Center for Interventional Vascular Therapy Columbia University Medical Center / New York-Presbyterian Hospital ) and Dr. Anson Cheung (Professor of Surgery and Director of Cardiac Transplant at St. Paul\'s Hospital, Vancouver Canada ).
Latest
news: * On October 9, 2014, OPKO Health announced that its investee, Neovasc, has received conditional Investigational Device Exemption (IDE) approval from the 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). With this FDA approval, TIARA-I is expected 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 now 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 .
