Neovasc has enrolled the first patient in the European arm of its TIARA-I early feasibility trial, a multinational, multicentre trial being conducted at centres in the USA, Europe and Canada to assess the safety and performance of Neovasc’s Tiara mitral valve system and implantation procedure in high-risk surgical patients suffering from severe mitral regurgitation.
The first patient was enrolled by Stefan Verheye, at the Antwerp Cardiovascular Centre / ZNA Middelheim, Belgium. The Tiara valve implantation was completed via a minimally invasive, transapical, transcatheter approach, resulting in elimination of the patient’s mitral regurgitationwithout leaks or other complications. To date, recovery of the patient has been uneventful.
“Experience to date with the first five patients receiving a Tiara replacement valve has been very encouraging with the transcatheter device being readily implanted through a transapical approach and functioning as intended to replace the diseased native valve,” says stated Neovasc chief executive officer Alexei Marko.
TIARA-I has received institutional review board approval from the first of the participating US medical centres and anticipates US implantations of Tiara to begin in the coming months. It is expected that additional European and Canadian sites will begin enrolling patients in early 2015.
Neovasc also confirmed that Tiara was implanted in a fourth Canadian patient at St Paul’s Hospital in Vancouver Canada under special access regulatory approval. This implantation was completed uneventfully and resulted in a well-functioning prosthetic valve with no residual mitral regurgitation, leaks or other complications. The patient was discharged home on day five following implantation and their recovery has been uneventful to date.