Colibri Heart Valve announced that the transcatheter aortic valve (TAVR) pilot study in the European Union (EU) has shown superior haemodynamics of its ready-to-use balloon-expanded valve.
The Centre Européen de Recherche Cardiovasculaire (CERC) conducted the study in the role of a clinical research organisation (CRO).
Claimed to be the first of its kind worldwide, this TAVR system utilises a pre-mounted, pre-packaged, dry tissue, ready-to-use balloon-expanded valve and a system design that eliminates the need for valve prosthesis mounting in the catheterisation laboratory.
The study’s principal investigator, Dr Bernard Chevalier from L’hôpital Privé Jacques Cartier in Massy, France, shared the initial 30-day findings. It involved 26 patients classified as high-risk for surgical aortic valve replacement.
These patients received the Colibri dry tissue TAVR valve through a pre-mounted, pre-packaged delivery system.
According to the company, all subjects survived the initial 30-day milestone.
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Central core laboratory measurements revealed that the haemodynamic valve performance was notably high, with a mean valve area of 2.23cm² and a mean Doppler index of 0.56 at 30 days.
Colibri expects that these results will provide significant validation for its pre-mounted TAVR valve.
University Hospitals Sussex structural heart disease head professor 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.”
Established in 2010, Colibri is focused on the development of new patent-protected, structural heart technologies.