(NVCN) today provided an update on its clinical program for the Tiara™ ("Tiara") valve, a self-expanding mitral bioprosthesis for transcatheter implantation in patients with Mitral Regurgitation ("MR"), one of the most prevalent valvular heart diseases in western countries. MR is often severe and can lead to heart failure and death.
In total, 47 patients have now been implanted with Tiara, 12 of which are enrolled in the Company's CE Mark trial, TIARA-II. Of note, 10 patients have been treated in the last two months, including 4 already in 2018. Fuelling the higher rate of procedures are the additional centres recently activated across Europe. This momentum is expected to continue as the Company expands both the number of centres and its clinical support teams.
Procedures are reported to be straightforward, with usual implantation times of approximately 20 minutes. 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. All cause 30-day mortality in the 42 patients who have reached 30 days post implant with Tiara is 9.5% (4/42). About Tiara
Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the U.S. with a similar number of patients affected throughout Europe. Tiara is implanted in the heart using a minimally invasive, transapical transcatheter approach without the need for open-heart surgery or use of a cardiac bypass machine.
About Neovasc
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Neovasc Reducer™, for the treatment of refractory angina, which is not currently available in the United States and has been available in Europe since 2015 and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under investigation in the United States, Canada and Europe. The Company also sells a line of advanced biological tissue products that are used as key components in third-party medical products including transcatheter heart valves. For more information, visit: www.neovasc.com.
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