Monday, January 27, 2020
Neovasc, Inc., a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced today that after further successful acute animal tests conducted earlier this week, a final design concept for the fully retrievable transfemoral trans-septal Tiara™ (“TF/TS Tiara”) system, including a modified, lower profile valve and a steerable delivery system, has been established and will now move into a design freeze phase review, in accordance with the Company’s quality system.
“The team has done an outstanding job, building on our extensive knowledge and clinical expertise with the Transapical Tiara (‘TA Tiara’) system, to define, what we view as, a truly transformational TF/TS Tiara system, where the trackability into the mitral valve annulus via single vein femoral access, the single piece self-anchoring design and full retrievability until the point of final release stand out as enabling key features. Additionally, we believe our highly trackable delivery system and lower valve profile should expand the potential treatable patient population,” commented Aaron Chalekian, Vice President of Product Development at Neovasc.
“We believe we are at the forefront of emerging developments to successfully deliver a mitral valve replacement device via the transfemoral trans-septal pathway in patients with severe mitral valve regurgitation, a major unmet medical need,” said Fred Colen, President and CEO of Neovasc, “Building on our successful TA Tiara program, which has treated 82 patients including the longest-living minimally invasive mitral valve replacement patient who is living with a markedly improved quality of life nearly six years post implant, we truly understand the enormously complex clinical and technical challenges for the transfemoral trans-septal device delivery. We are confident that with this steerable delivery system and modified, lower profile valve, we will be able to successfully treat a very large patient population in need of such a life-changing valve replacement device. We look forward to achieving the next major development milestones in this program.”
