Successful clinical use of Colibri's TAVI system completed
Colibri Heart Valve has successfully completed the first clinical use of the its proprietary transcatheter aortic heart valve. The Colibri transcatheter aortic valve implantation (TAVI) system is said to be the world's first and only low profile, 14Fr pre-mounted, pre-crimped and pre-packaged, ready-for-use, TAVI system. These advantages are designed to reduce delivery profile along with a reduction in preparation and insertion time that are believed to not be available in any other device, either currently available or in known development. The company's tissue processing method produces extremely strong, durable and biocompatible tissue. The proprietary tissue enables loading, crimping and packaging of the Colibri valve at manufacture, making in-procedure valve rinsing and loading at time of use unnecessary.
The patient was treated as part of Colibri's first-in-human feasibility study, an international prospective, multicentre, non-randomised, investigational study to assess the safety, technical feasibility, and deployment characteristics of the 24mm Colibri aortic heart valve and delivery system. Enrolment in the ongoing study of the Colibri TAVI system in up to ten patients is taking place at multiple trial sites outside the US and is expected to yield 30-day follow-up data by the end of the first quarter of 2013. 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.