Vancouver-based Neovasc said the federal safety watchdog approved the use of the 40mm Tiara device in its 30-patient Tiara-I early feasibility study, which was already approved for the 35mm valve. Neovasc has also said it’s developing a 45mm valve size.
“We believe the addition of the 40mm size is an important step in the Tiara program and should significantly increase the number of patients eligible for treatment,” CEO Alexei Marko said in prepared remarks. “With both the 35mm and 40mm sizes now available, we are continuing development activities to bring additional sizes into clinical use.”
As of Nov. 9, 2015, 11 patients had been implanted with Tiara in early feasibility and compassionate use cases, Neovasc said at the time.