Neovasc has an advanced new transfemoral trans-septal Tiara (TF / TS Tiara) design concept after carrying out successful acute animal tests to develop a device to treat patients with severe mitral valve regurgitation.
Based in Richmond, Canada, Neovasc develops, manufactures and markets products for the cardiovascular marketplace.
The company has two products, Tiara, for the transcatheter treatment of mitral valve disease and Reducer, for the treatment of refractory angina.
Similar to Neovasc’s Tiara transapical programme, the TF / TS development programme comes from a concept that facilitates a controlled and predictable implantation procedure.
Neovasc president and CEO Fred Colen said: “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.
“Building on our successful TA Tiara programme, 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.
Neovasc expects to begin a clinical feasibility study later this year.
Neovasc product development vice president Aaron Chalekian said: “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.”