Canada-based Neovasc has unveiled a final design concept for its fully retrievable transfemoral trans-septal Tiara (TF/TS Tiara) system, following the rigorous testing on animals in the earlier week.
The company said that its new TF/TS Tiara system has been designed to include a modified, lower profile valve and a steerable delivery system.
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 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.”
Neovasc has tested its TF/TS Tiara system through five acute animal trials
The company said that the development program of TF/TS is based on a concept that allows for a very controlled and predictable implantation procedure similar to its Tiara transapical program.
The TF/TS Tiara system has been tapered down to a system design concept, involving a new delivery system combined with a lower-profile valve implant that shows strong potential.
Neovasc said that it has conducted various evaluations using in vitro test methods, including system trackability, deployment accuracy, and hydrodynamic assessment, along with five acute animal trials. The company intends to start a clinical feasibility study in late 2020.
Neovasc is a medical devices manufacturer engaged in providing minimally invasive transcatheter mitral valve replacement technologies and developing minimally invasive devices for refractory angina.
Colen added: “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.”
