US-based Colibri Heart Valve has released the clinical update from the first-in-human study of its proprietary 24mm transcatheter aortic valve implantation (TAVI) system.
The company has developed a pre-mounted and pre-packaged, ready-for-use transcatheter aortic valve implantation (TAVI) device called the Colibri TAVI system.
The five patients enrolled in the study continue to demonstrate successful outcomes with zero-to-trace paravalvular leak (PVL) and a high retrained effective orifice area (EOA) of greater than 2.0 cm2 up to one year post implantation.
The results suggest that Colibri’s valve design may have superior patient benefits over current transcatheter heart valves, with no femoral complications or stroke, and no need for pacemaker implantation.
Colibri president and CEO Joseph B. Horn said, "We believe these patient outcomes are directly related to the design features of the Colibri TAVI valve, which uses a proprietary leaflet design that optimizes opening and closing valve behavior while being delivered through a low profile 14Fr catheter."
TAVI is an important treatment option for heart valve replacement due to its minimally invasive nature, clinical efficacy, extensive patient experience, and reduced procedural costs.