Vancouver-based Neovasc said 47 patients have been implanted with the Tiara transcatheter mitral valve replacement using a roughly 20-min. procedure, with 42 reaching the 30-day mark. The all-cause mortality rate at that point was 9.5%, the company said.
“Technical success rates are very high, and typically result in the complete resolution of the patient’s MR; paravalvular leak levels are reported as absent, trace, or mild, in 100% of these cases,” Neovasc said.
“For those of us who have been close to Tiara’s development since its inception, what is so encouraging is both the quality of the data and now the quantity of cases strongly suggest what we have long believed. Namely, that Tiara has the very real potential to be a best-in-class therapeutic treatment for millions of patients suffering with severe MR,” CEO Alexei Marko said in prepared remarks. “Throughout 2018, our primary focus will be the TIARA-II trial, as we aggressively drive this medical device towards CE Mark.”
Twelve of the 47 enrolled patients are participating in the Tiara II study, the company said. That trial, slated to enroll up to 115 patients, is designed to follow them at 90 days, 180 days, one year and annually thereafter for five years, according to ClinicalTrials.gov.
NVCN shares were up 1.8% to 57.31¢ today in mid-morning trading.
A jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing the Tiara TMVR (Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014). A federal judge in Massachusetts added $21 million in enhanced damages to the decision in November 2016.