"In total, 47 patients have now been implanted with Tiara, 12 of which are enrolled in the Company's 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). "