Only Ready-For-Use TAVI System:
The Colibri Transcatheter Aortic Valve Implantation (“TAVI”) System is expected to redefine transcatheter aortic heart valve implantation as it is the World’s first and only, low profile pre-packaged TAVI system designed to be shipped sterilized and ready-for-use.
Competing technologies must be shipped to customers “wet” in toxic preservation solutions and require cleaning and crimping at the point of use – the Colibri TAVI System does not.
Pre-mounted, Pre-crimped, and Pre-packaged at Manufacture:
The Colibri transfemoral TAVI System is pre-mounted, pre-crimped, and pre-packaged at manufacture. Colibri’s manufacturing process provides significant operational, quality, and cost advantages over traditional “wet” technologies as it ensures accurate valve placement on the delivery system and eliminates the cleaning and crimping of valves at the point of use.
Delivered Through 14 Fr Sheath:
The Colibri TAVI System is delivered through a 14 French (14 Fr) sheath providing major benefits in reducing procedural issues such as femoral complications. The low profile of the Colibri TAVI System can expand the addressable market by accelerating adoption in developing countries and enabling treatment of patients that are currently excluded due to small femoral artery size.
Balloon Expandable Delivery System:
The Colibri TAVI System utilizes a custom-made non-compliant, high pressure dual balloon expandable delivery system to deploy the stainless steel frame of the Colibri heart valve. The Colibri delivery system utilizes an inner stabilizing and outer deployment balloon for valve deployment. The noncompliant balloon material provides controlled valve expansion and a high RBP of 7 ATM.
Colibri’s balloon expandable delivery system incorporates additional advantages beyond deployment to reduce the risk of balloon related complications. These advantages include a reduction in the overall balloon length by having very short proximal and distal tapers of the balloon resulting in a reduced inflation volume and rapid inflation and deflation times. This design also provides a delivery system that is better suited for patients with a small left ventricle as it reduces the risk of potential damage to the left ventricle during orthotopic anatomical deployments.
The Colibri TAVI System is supported with over 10 years of product development and incorporates advantages not available in any other TAVI device, either available or in known development.