Neovasc has secured regulatory and ethics committee approval in Italy to commence the CE mark Tiara transcatheter mitral valve replacement study (TIARA II).
TIARA II is a non-randomized and prospective clinical study that will recruit around 115 patients to assess the safety and performance of the Tiara transcatheter mitral valve with the Tiara transapical delivery system.
Neovasc plans first enrollment in Italian trial in the new year, and is expecting approvals for the study in additional geographies in the first quarter of the same year.
The company will use the data from the trial to file for for CE mark approval for Tiara system.
Tiara is a self-expanding mitral bioprosthesism which will be used to treat mitral valve regurgitation (MR) by replacing the diseased valve.
Through using a minimally invasive and transapical transcatheter approach, Tiara will be implanted in the heart to replace the diseased native mitral valve without the need for open-heart surgery or use of a cardiac bypass machine.
Neovasc CEO Alexei Marko said: "Tiara has been successfully implanted in a wide range of patients including those with prosthetic aortic valves in place (both tissue and mechanical valves) and those with prior mitral valve surgical repairs, including mitral rings.
“With this approval, we look forward to beginning our CE mark study which offers a less invasive treatment option for patients determined to be high risk for surgery, suffering from severe MR, and to eventually have Tiara available as a treatment option for clinical use to treat this devastating disease."