The Vancouver-based company said that to date 34 patients have been treated with the Tiara at 10 centers globally, with a technical implantation success rate of 91.1%.
Of the successful implantations, 100% of paravalvular leaks were reported as mild, trace or absent. The longest surviving patient has passed 3.5 years since implantation, Neovasc said.
Currently, implantations of the experimental device are being performed as part of a European pivotal CE Mark trial, an FDA early feasibility trial in the US and under compassionate use and special access treatment. The CE M
Neovasc has received regulatory approval to conduct the TIARA-II study at a total of 10 centers; five in Italy, three in Germany, and two in the United Kingdom. The TIARA-II study, which is the primary focus of the Tiara program, is a 115-patient, nonrandomized, prospective clinical study evaluating Tiara’s safety and performance. It is expected that data from this study will be used to apply for CE Mark approval in Europe.ark trial is slated to enroll 115 patients, the company said.
Neovasc said it has recruited 2 new US centers to participate in the FDA feasibility Tiara-I study, and that it is recruiting patietns at 8 other centers.
Anson Cheung, MD, a Principal Investigator of the TIARA-I study, will present an update on the Neovasc Tiara program at PCR London Valves 2017 conference to be held September 24–26 in London, United Kingdom. On September 9 in San Francisco, California, Paulo Denti, MD, Principal Investigator at San Raffaele Hospital in Milan, Italy, presented a Tiara case at CSI-UCSF 2017, a conference hosted by the CSI Foundation in association with the University of California, San Francisco, noted the company.