News | August 14, 2013

Colibri Continues Enrollment in Feasibility Study of the First Ready-to-Use Transcatheter Heart Valve System

Early results from the second implantation confirm positive findings from its first use

August 14, 2013 — Colibri Heart Valve LLC announced that enrollment its first-in-human feasibility clinical study is continuing, and early clinical results from the second implantation of the Colibri device confirm the positive clinical findings observed in its first use. The Colibri transcatheter aortic valve implantation (TAVI) system is the first low profile, 14 French, pre-mounted, pre-crimped, and pre-packaged, ready-for-use TAVI system.

"The results seen to date from additional enrollment in our feasibility study support the excellent clinical results seen in the first patient to undergo the implantation procedure," stated Joseph B. Horn, Colibri's president and CEO. "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 greater than 2.0 and virtually no paravalvular leakage (PVL), which we believe may point to superior clinical outcomes.”

"The low profile (14 French) of the Colibri TAVI System greatly improved the ease with which the mounted TAVI System is navigated through the vasculature (trackability) and positioning of the replacement heart valve in the native aortic valve plane compared to other TAVI systems," stated Dr. Pedro Ureña, one of the primary investigators of the Colibri clinical study and the director of the cardiovascular department at the Center of Advanced Medicine (CEDIMAT) in Santo Domingo, Dominican Republic. "The combination of these benefits and the convenience of receiving the Colibri TAVI system pre-packaged and ready-for-use are significant improvements that I look forward to confirming with additional enrollment in the study."

Colibri's first-in-human feasibility study 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. Enrollment in the ongoing clinical study of the Colibri TAVI system in up to 10 patients is taking place at multiple trial sites outside the United States and is expected to yield 30-day follow-up data by the TCT 2013 meeting this fall in San Francisco. To be eligible for the study, individuals must have severe symptomatic aortic valve stenosis and be very high risk for open-heart valve replacement surgery. Study participants will be monitored at 30 days and one year following implantation.

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