US-based medical device company Colibri Heart Valve has unveiled the initial findings of a multicentre high-risk EU pilot study of its transcatheter aortic valve replacement (TAVR) system.

The study was conducted by Centre Européen de Recherche Cardiovasculaire (CERC) as an acting clinical research organisation (CRO).

Its principal investigator Bernard Chevalier presented the initial 30-day endpoint results of the clinical trial in the 26 patients, classified as high-risk for surgical aortic valve replacement.

The study participants received the Colibri dry tissue TAVR valve, delivered using the pre-mounted, pre-packaged delivery system.

In the pilot study, all the patients survived until the initial 30-day milestone.

University Hospitals Sussex in Brighton, UK, structural heart disease head David Hildick-Smith 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.”

The central core laboratory measurements showed superior hemodynamic valve performance for the TAVR system, including a mean valve area of 2.23cm2 and a mean Doppler index of 0.56 at 30 days.

The report validates Colibri’s TAVR system, and the hemodynamic performance of its advanced leaflet design surpasses the predicate balloon expanded TAVR valves.

It is the world’s first TAVR system using a pre-mounted, pre-packaged, dry tissue, ready-to-use balloon-expanded valve and system design that does not involve mounting the prosthesis in the catheterisation laboratory.

Colibri said that the results provide strong validation of its advanced pre-mounted TAVR valve and is looking forward to initiating the US Food and Drug Administration (FDA) feasibility trials.