Colibri's transcatheter aortic valve [TAVR] EU pilot study validates its pre-mounted, pre-packaged, dry tissue, ready-to-use balloon-expanded valve with demonstration of superior hemodynamics
01 Dec 2023
Clinical Result
LOUISVILLE, Colo., Dec. 1, 2023 /PRNewswire/ -- The initial findings of Colibri Heart Valve's multicenter high-risk TAVR EU pilot study were presented at PCR London Valves November 20th, 2023. The study was conducted by CERC (Centre Européen de Recherche Cardiovasculaire) as acting CRO (clinical research organization).
Speaking on behalf of the study's team of investigators, Dr Bernard Chevalier, principal investigator, L'hôpital Privé Jacques Cartier, Massy, France, presented the primary 30-day endpoint results of the trial in the 26 patients, classified at high-risk for surgical aortic valve replacement, who received the Colibri dry tissue TAVR valve utilizing the pre-mounted, pre-packaged delivery system. All patients survived to the initial 30-day milestone. Central core laboratory measurements indicated notably high measures of hemodynamic valve performance, including mean valve area of 2.23 cm2 and mean Doppler index of 0.56 at 30 days.
The report represents major clinical validation of Colibri's ground-breaking, world's first TAVR system utilizing a pre-mounted, pre-packaged, dry tissue, ready-to-use balloon-expanded valve and system design that does not involve mounting of the valve prosthesis in the catheterization laboratory. The hemodynamic performance of Colibri's unique, innovative leaflet design appears to surpass that of predicate balloon-expanded TAVR valves.
Professor David Hildick-Smith, Head of Structural Heart Disease at the University Hospitals Sussex in Brighton, UK, said "The Colibri pre-mounted TAVI system is very straightforward and efficient. It comes preloaded in its packaging – just like a coronary stent does. We can take the system directly from its packaging and implant it in the patient. There is no need for valve crimping, loading, or other technical assistance. Furthermore, and crucially, the valve area obtained is significantly greater than with other valve systems, and this may prove very advantageous in terms of symptom resolution and valve durability."
Colibri believes these results provide strong validation of its innovative pre-mounted TAVR valve—the first truly ready-to-use valve system that will set a new standard in structural heart technology, and the company now looks forward to launching its FDA feasibility trials.
About Colibri Heart Valve:
Colibri Heart Valve LLC ("Colibri") is a privately held medical device company that researches and develops novel, patent protected, structural heart technologies. Colibri was formed in 2010 and through its proprietary tissue technology and valve design, Colibri has developed a pre-mounted, pre-crimped, and pre-loaded, Ready-for-Use balloon expandable transcatheter aortic valve implantation (TAVI) system called the "Colibri TAVI System." The Colibri technology is protected by both trade secrets and issued and pending patent applications with priority claims and content dating back to January 4, 2002. https://www.colibrihv.com
For more information please contact:
Thomas Wolf 303-808-2570.
SOURCE Colibri Heart Valve
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