Acute results from a preclinical study published in the Journal of the American College of Cardiology (JACC) suggest that the initial experience with the Neovasc Tiara™ transcatheter mitral valve was encouraging and that implantation of Tiara valves was feasible, relatively straightforward and resulted in a securely-implanted, well-functioning device that maintained good hemodynamics in the test animals.
Neovasc’s Tiara device is designed to be delivered through the apex of the heart or alternatively transvenously to restore normal function of the mitral valve while preserving the integrity of its surrounding structures. The company is not alone in attempting to exploit the market opportunity represented by transcatheter mitral valve replacement as we’ve alluded to on many occasions on our pages. However, getting there is no mean feat, not least because of the complex etiology of mitral regurgitation, such as ring dilation, chordae rupture, or cusp damage to name a few. So its not altogether surprising to see the company guardedly welcoming the news of what is presumably a pivotal piece of preclinical work.
In the published study, Tiara valves were implanted successfully in 81% of the test animals, with total procedure times ranging from 17 to 26 minutes. In the successful implantations, angiographic and echo imaging demonstrated excellent function of the Tiara, with no obstruction of the left ventricular outflow tract, no pericardial effusion, no encroachment on the aortic valve, no transvalvular gradients and most importantly, no significant paravalvular leak. All animals remained hemodynamically stable during the implant procedure without the need for rapid pacing.
The study, which will be published in the October 9, 2012 edition of JACC, is currently available on-line.
“We are very pleased with the results of our Tiara implantations in preclinical animal models,” noted Alexei Marko, CEO of Neovasc. “Publication of the first results from the acute phase of these studies in a prestigious journal such as JACC highlights the potential value of Tiara for the treatment of patients with mitral regurgitation who cannot be treated surgically. We look forward to sharing long-term Tiara results from studies in chronic animal models at TCT 2012 next month.”
Reference: The report, Tiara: A Novel Catheter-Based Mitral Valve Bioprosthesis: Initial Experiments and Short-Term Pre-Clinical Results, was authored by Shmuel Banai, MD, E. Marc Jolicoeur, MD, Marc Schwartz, RCIS, Patrick Garceau, MD, Simon Biner, MD, Jean-Francois Tanguay, MD, Raymond Cartier, MD, Stefan Verheye, MD, Christopher J. White, MD and Elazer Edelman, MD, PhD. It is being published in the Journal of the American College of Cardiology, Vol. 60, # 15, 2012, and is currently available on-line at: http://content.onlinejacc.org/article.aspx?articleid=1358177.
Source: NeoVasc Inc., PR Newswire