Neovasc announced the US Food and Drug Administration (FDA) has granted approval for participating physicians to treat patients with its 40mm Tiara valve in the Company's TIARA-I Early Feasibility Trial.
"We believe the addition of the 40mm size is an important step in the Tiara program and should significantly increase the number of patients eligible for treatment," stated Neovasc CEO Alexei Marko.
"With both the 35mm and 40mm sizes now available, we are continuing development activities to bring additional sizes into clinical use".
The TIARA-I Early Feasibility Trial is a multinational, multicenter trial being conducted at centers in the US, Europe and Canada 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.
Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the US.
alone. 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