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November 18, 2019

Neovasc's Tiara System Early Data Presented in a Conference Tutorial Session

November 19, 2019—Neovasc, Inc. announced its Tiara transfemoral/transseptal (TF/TS) system was featured in a tutorial session focusing on the early clinical outcomes for patients undergoing transcatheter mitral valve replacement at the PCR London Valves 2019 meeting, held November 17–19 in London, England. Anson Cheung, MD, Clinical Professor of Surgery and Director of Cardiac Transplant of British Columbia, and Principal Investigator for the TIARA-I early feasibility study at St. Paul’s Hospital, Vancouver, British Columbia, Canada, presided over the session.

These initial data included outcomes for 71 of the 80 high-surgical-risk patients treated with the transapical (TA) Tiara system as part of the TIARA-I trial, TIARA-II CE Mark study, or for compassionate use cases. The 30-day survival rate for patients treated with the TA Tiara system was 89%, with one patient currently surviving for more than 5 and a half years after implantation. Procedural success was 94%; procedural mortality was 0%. Additionally, it was reported that the resolution of mitral regurgitation (MR) was observed in most cases, with no or trace MR in 88% of patients at discharge.

According to Neovasc, the TF/TS Tiara system builds on the success of the TA Tiara system with a new, lower-profile implant and the potential for a less invasive delivery via a vein in the groin.

The company explained that it is continuing experimental design studies for the TF/TS Tiara system to optimize the final design. Neovasc intends to reach a design freeze by the end of 2019 and expects to initiate a clinical feasibility study in late 2020.

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November 19, 2019

BioVentrix's Revivent TC System Receives FDA Breakthrough Device Designation

November 19, 2019

BioVentrix's Revivent TC System Receives FDA Breakthrough Device Designation