Neovasc has received FDA conditional approval to initiate its TIARA-I Trial in the USA. The multinational, multicentre early feasibility trial will evaluate the safety and performance of the company’s Tiara mitral valve system and implantation procedure in high-risk surgical patients with severe mitral regurgitation.
This FDA conditional approval allows clinical investigators to begin enrolling patients at participating USA medical centres once local hospital and related approvals are in place.
The TIARA-I Early Feasibility Trial will enrol up to 30 patients globally and is being overseen by a multidisciplinary committee of internationally recognized physicians co-chaired by Martin Leon (director, Center for Interventional Vascular Therapy Columbia University Medical Center / New York-Presbyterian Hospital, New York, USA) and Anson Cheung (Professor of Surgery and Director of Cardiac Transplant at St. Paul’s Hospital, Vancouver, Canada). Following this FDA approval, TIARA-I is expected to enrol patients at three highly respected US medical centres: Columbia University Medical Center/New York-Presbyterian Hospital (New York), Lenox Hill Hospital (New York) and Cedars-Sinai Medical Center (Los Angeles).
“We are delighted that after review of the early feasibility investigational device exemption (IDE) submission, the FDA has granted this conditional approval,” states Neovasc chief executive officer, Alexei Marko. “This is an important step towards Tiara becoming one of the first transcatheter mitral valve replacement devices available for treating US patients. We look forward to working very closely with the participating investigators to complete TIARA-I and to help address this urgent clinical need.”
A press release reports that the company is now focusing on training participating clinical teams and obtaining institutional approvals with the goal of enrolling the first US patients by early next year. It adds that the TIARA-I Trial also has received ethics committee approval at Antwerp Cardiovascular Center / ZNA Middelheim in Belgium and competent authority notification is pending. First European enrolment is expected before the end of the year. Applications are underway for additional centres in Europe and Canada.