Colibri recently initiated a clinical early feasibility study (EFS) which is an international prospective, non-randomized, single arm, open label, trial to assess early feasibility of the Colibri second-generation 24mm and 27mm percutaneous, ready-for-use, balloon expandable aortic heart valve and delivery system. The company’s second-generation TAVI system includes enhancements to address a wider range of patient candidates including those with bicuspid aortic valves and younger patients that need a more durable valve.
The first two (of up to 10) patients with severe aortic stenosis were recently enrolled in the Colibri EFS. The patients were successfully treated with a 27 mm Colibri TAVI System and demonstrated post-implantation single digit mmHg mean aortic valve pressure gradients and no observed paravalvular leakage (PVL) or aortic insufficiency (AI). As represented by one of the first two cases below, the Colibri TAVI System was successfully advanced and positioned across the stenotic aortic valve. The balloon expandable delivery system provided stable and accurate valve deployment.
Enrollment in the clinical study of the Colibri TAVI system in up to 10 patients is taking place and is expected to yield 30-day follow-up data which will be presented at an upcoming medical conference. Please check back for updates on the Colibri EFS and other clinical development.
In addition to the recently initiated Colibri EFS, Colibri Heart Valve successfully conducted a First-in-Human clinical study at the Cardiovascular Department at the Center of advanced medicine (CEDIMAT) in Santo Domingo, Dominican Republic, in five (5) subjects with the first-generation balloon expandable Ready-for-Use Colibri TAVI System in 2012-2013. Analysis of the data from patients enrolled in this study yielded clinical outcomes that met the study’s endpoints with successful patient follow-up out to ~5 years post implantation. Please reference the following peer-reviewed publications summarizing Colibri’s first clinical experience (click here for peer-review publication).