Acute results from preclinical studies of the Tiara valve (Neovasc) for the transcatheter treatment of mitral regurgitation have shown that implantation of Tiara valves was feasible, relatively straightforward and resulted in a securely-implanted, well-functioning device that maintained good haemodynamics in the test animals.
The study, which will be published in the 9 October 2012 edition of the Journal of the American College of Cardiology (JACC), is currently available on-line.
“We are very pleased with the results of our Tiara implantations in preclinical animal models,” said Alexei Marko, CEO, 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.”
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 haemodynamically stable during the implant procedure without the need for rapid pacing.
The report titled “Tiara: A novel catheter-based mitral valve bioprosthesis: initial experiments and short-term pre-clinical results”, was authored by Shmuel Banai, E Marc Jolicoeur, Marc Schwartz , Patrick Garceau, Simon Biner, Jean-Francois Tanguay, Raymond Cartier, Stefan Verheye , Christopher J White and Elazer Edelman.