Neovasc Reports First Human Implant of Tiara Transcatheter Mitral Valve

Neovasc Inc. has conducted the first human implantation of its Tiara transcatheter mitral valve at St. Paul’s Hospital in Vancouver, British Columbia. The transapical procedure resulted in the elimination of mitral regurgitation (MR) and significantly improved heart function in the patient, without the need for cardiac bypass support and with no procedural complications, the company claimed.

The implantation was conducted by Anson Cheung, M.D., professor of Surgery and director of Cardiac Transplant, and John Webb, M.D., director of Interventional Cardiology, at St. Paul’s Hospital. They were supported by Stefan Verheye, M.D., senior interventional cardiologist at the Antwerp Cardiovascular Center/ZNA Middelheim in Belgium, and Shmuel Banai, M.D., medical director of Neovasc and director of interventional cardiology at Tel Aviv Medical Center in Israel.

“This 73 year-old male patient had severe functional mitral regurgitation and was considered an extremely high risk candidate for conventional valve repair or replacement surgery,” Cheung said. “The transapical implantation of the Tiara valve was completed quickly and without complications. It resulted in a well-functioning bioprosthetic valve with no significant paravalvular leak or residual MR. We are very pleased that this first implantation went so smoothly and that the patient’s outcome to date is so positive. His recovery has been uneventful, and we will continue to follow him closely over the coming months. The ability to implant a prosthetic mitral heart valve using a transcatheter, minimally-invasive approach instead of conventional open chest, open heart surgery would provide a much-needed alternative for the many patients who are considered at high risk for conventional surgery.”

Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation, a serious and poorly-served condition that requires development of highly specialized devices to address the complex mitral anatomy. Significant mitral regurgitation can lead to heart failure and death. Conventional surgical treatments are only appropriate for about half of the estimated 4 million MR patients in the United States.

Tiara is implanted in the heart using a minimally-invasive, 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.

Neovasc Inc. is a British Columbia company that develops, manufactures and markets cardiovascular products. Its products include the Neovasc Reducer for the treatment of refractory angina and the Tiara transcatheter mitral value replacement device in development for the treatment of mitral regurgitation. The firm’s investors include multi-national biopharmaceutical and diagnostics company OPKO Health Inc.