US-based Colibri Heart Valve has implanted the first patient with its proprietary transcatheter aortic valve implantation (TAVI) system, as part of first-in-human feasibility study.
The investigational, multicentre, non-randomised, prospective study will enrol up to ten patients and evaluate the safety, technical feasibility and deployment characteristics of the 24mm Colibri transcatheter aortic heart valve in patients with severe symptomatic aortic valve stenosis who are at high risk of needing open-heart valve replacement therapy.
The study is expected to yield 30-day follow-up data by the end of the first quarter of 2013.
The ready-for-use Colibri TAVI is a low profile system that incorporates a 14 French introducer, the smallest available, and is pre-mounted, pre-crimped and pre-packaged.
Colibri president and CEO 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 said.
The TAVI procedure was performed at the Centre of Advanced Medicine (CEDIMAT) in Santo Domingo, Dominican Republic, using Colibri system in a female patient with extensive calcification of aortic valve, according to the company.
Centre of Advanced Medicine Cardiovascular Department director and procedure surgeon Dr Pedro Urenya said in comparison to other TAVI systems, the time taken from removing the valve from its sterile package to valve deployment was much shorter than with other system,s.
"The relatively short pre-procedure requirement also reduced the time the patient was under anesthesia, an important factor for high risk patients, and allowed my staff to devote more time to patient care," Urenya said.