Colibri Valve Design:
- Proprietary folded valve design maximizes durability and functionality and reduces required suture
- Lowest-profile TAVI system; 14Fr
- Leaflet functionality of native valve
- Valve tissue 3-5X stronger than competing tissue(s)
- Large Aeo and low gradient provides high efficiency and reduced load on the heart
- Competent leaflet function in out-of-round and diverse anatomical structures
Proprietary Folded Valve Design:
The Colibri heart valve leaflets are formed from three independent pieces of proprietary porcine pericardium which are created using a unique folding method. The folded design of the leaflets reduces the amount of material in the frame and minimizes the number of sutures required to manufacture the valve. The proprietary Colibri design reduced the number of sutures to less than 200 while increasing durability and functionality. Competing technologies utilize 1,500+ sutures. The Colibri valve design allows for an unprecedented profile reduction minimizing the profile of a crimped valve.
The balloon-expandable laser-cut stainless steel frame was designed specifically for the Colibri tissue to maximize durability and functionality. The integrated leaflet and frame design ensures there are no sutures in stress-bearing locations or high-motion surfaces, making the valve highly functional and very durable. This folding technique streamlines the manufacturing process and aids in reducing the profile.
The three independent leaflets naturally come together within the frame to form an elegantly functioning aortic valve. The independent leaflet design allows the valve to naturally adjust to out-of-round positions and compensate for a leaflet if one becomes compromised in any way. The Colibri valve design incorporates an abluminal tissue skirt to address perivalvular leaking. The end result is an eloquent and durable TAVI valve that functions like a native valve.
The 24mm Colibri aortic heart valve has been advanced into clinical testing. The folded design is scalable with 21, and 27mm Colibri aortic heart valve applications under development and testing.
Colibri has conducted extensive pre-clinical testing on its heart valve technology, including successful accelerated wear testing to over 200 million cycles. The 24mm CHV has a large effective orifice area (“Aeo”) of ≥2.5 at normal CO (5L/min, 100mmHg mean aortic pressure, 35% systolic duration) as tested by third party laboratories.
Colibri’s proprietary porcine pericardial tissue has been tensile tested head-to-head against competitors traditional “wet” valve tissues and was found to be 3-5x stronger in these tests with an average UTS of >30 MPa. Numerous animal implantation studies have been conducted and demonstrated successful valve deployment, function, and biocompatibility of the Colibri TAVI System.
Data on file; Colibri Heart Valve, LLC