Neovasc (NSDQ:NVCN) today updated on the clincial study of its Tiara self-expanding transcatheter mitral valve bioprosthesis designed to treat mitral regurgitation, touting 31 successful implants and a 12.1% rate of 30-day mortality.
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 Mark 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.
“Transcatheter implantation of the Tiara mitral valve resulted in immediate elimination of MR and improved the performance of the heart, without the need for any cardiac support device and with no procedural complications. The results we see so far are very encouraging in this very sick and high-risk patient population. These patients with severe MR and severe heart failure tolerate the Tiara implantation procedure without any major issues, and most of them are discharged home 3-5 days after the valve implantation,” Tiara CE Mark trial principal investigator Dr. Ulrich Schafer of the University Heart Center Hamburg said in a press release.
Shares in Neovasc have risen 8.4% so far today, at $1.26 as of 10:54 a.m. EDT.
Earlier this month, Neovasc saw its shares jump 45% after a federal appeals court upheld a district court ruling in a trade secret spat with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve, affirming a decision not to enjoin its Tiara program.
With the decision, Neovasc will be required to pay the full judgement of approximately $112 million to Edwards, of which the company said $70 million is already held in an escrow account.