US-based healthcare company Colibri Heart Valve Colibri) has reported that enrollment in the first-in-human feasibility study of its ready-to-use transcatheter aortic valve implantation (TAVI) system is continuing at multiple sites outside the US.
Colibri TAVI TAVI system is a low profile, 14 French, pre-mounted, pre-crimped, and pre-packaged, ready-for-use system that can easily navigate through the vasculature and position the replacement heart valve in the native aortic valve plane.
Colibri president and CEO Joseph B Horn noted that the till date results from additional enrollment in the feasibility study support the excellent clinical results seen in the first patient to undergo the implantation procedure.
"While it is still early, the results demonstrate the system’s ease of use and benefit of its low profile. Moreover, we have continued to see an effective orifice area of >2.0 and virtually no paravalvular leakage (PVL), which we believe may point to superior clinical outcomes.
"We look forward to continued enrollment in our study to confirm the potential benefits of the Colibri TAVI System," Horn added.
The ongoing trial is an international prospective, multicenter, non-randomized, investigational study to assess the safety, technical feasibility, and deployment characteristics of the 24mm Colibri aortic heart valve and delivery system.
The enrollment of up to ten patients is likely to result in 30-day follow-up data, which is expected to be presented at the TCT 2013 meeting in San Francisco in October.
Individuals who suffering with symptomatic aortic valve stenosis and are at high risk for open-heart valve replacement surgery are being enrolled for the study.
The participants will be monitored at one month and one year following implantation of the device.