Neovasc, 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 achievement of design freeze for its fully retrievable transfemoral trans-septal Tiara™ (“TF/TS Tiara”) system, including a modified, lower profile valve and a steerable delivery system.

“This design freeze is a significant milestone for the Company,” commented Fred Colen, President and Chief Executive Officer at Neovasc. “We have advanced our program and met our quality system phase gate review for developing a transformational TF/TS Tiara system that offers meaningful advantages for physicians and patients. The trackability, single piece self-anchoring design, large valve opening area, lower profile valve and full retrievability until the point of final release combine to make what we believe to be a best-in-class system.”

The TF/TS Tiara System allows for a controlled and predictable implantation procedure similar to Neovasc’s Tiara transapical device. Unlike competitive systems in development, the TF/TS Tiara system features a single piece design that does not require a two-stage deployment process nor a docking mechanism for valve securement.

The single piece design allows for a simplified stepwise deployment and maintains a large valve opening, or effective orifice area, to maximize blood flow through the valve. The lower profile valve design, coupled with the innovative delivery system should expand the potential patient pool eligible for treatment. The Company expects to initiate a clinical feasibility study in late 2020.

Source: Company Press Release