Colibri Heart Valve, LLC of Broomfield, Colorado announced that its transcatheter aortic heart valve was implanted successfully for the first time at the Center of Advanced Medicine (CEDIMAT) in Santo Domingo, Dominican Republic.
The valve is delivered through a 14 French introducer, the smallest in the industry, allowing its use in patients with narrow vasculature and more difficult anatomies. The current device is 24mm in size and 21mm and 27mm diameters are in development.
Valve design features from the product page:
- 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
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.
Product page: Colibri heart valve…