Colibri Heart Valve in the US has treated the first patient with its proprietary 24mm Colibri transcatheter aortic valve implantation (TAVI) system, as part of first-in-human feasibility study.
The investigational, multicenter, non-randomized, prospective study will enroll up to 10 patients, is designed to assess the safety, technical feasibility, and deployment characteristics of the TAVI system.
The study, which is expected to yield 30-day follow-up data by the end of the first quarter of 2013, will enroll patients with severe symptomatic aortic valve stenosis who are at high risk of needing open-heart valve replacement therapy.
The low profile Colibri TAVI is a ready-for-use system including 14 French pre-mounted, pre-crimped, and pre-packaged advantages.
Colibri president and chief executive officer Joseph Horn said the proprietary system enables physicians and hospitals to measurably simplify and reduce pre-procedure preparation time and therefore overall cost.
"In addition, we believe the low profile 14 French introducer used in our system has the potential to be used in patients not currently considered TAVI candidates due to the relatively small diameter of their femoral arteries, thereby increasing the number of TAVI femoral patients who may benefit from this procedure," Horn added.