Vancouver-based company Neovasc Inc. has seen a first-in-human implantation of its Tiara™ transcatheter mitral valve, bringing a step closer the reality of a transcatheter option for mitral valve insufficiency.
We’ve followed NeoVasc with its Tiara mitral valve for over a year now, since the company reported its first acute preclinical trial results late in 2012, here.
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 four million MR patients in the US alone.
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.
This first human implantation was performed on January 30th by physicians at St. Paul’s Hospital in Vancouver, BC. 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.
Commenting on the procedure, Dr. Anson Cheung, Professor of Surgery and Director of Cardiac Transplant stated, “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. 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.”
Dr. Cheung added, “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.”
Source: Opko Health, Inc., Business Wire