Colibri Heart Valve Announces First Patients Enrolled in TAVI System Pilot Study

November 3, 2021—Colibri Heart Valve LLC announced the initiation of an international, CE Mark-enabling pilot study of the Colibri transcatheter aortic valve implantation (TAVI) system. The first patients were enrolled in Toulouse, France, with additional study sites expected to open in the United Kingdom later this year. The study enrolls patients with severe aortic stenosis who are at high surgical risk.

The ongoing pilot study objective is to evaluate the safety and performance of the Colibri TAVI system. Enrolled patients will be monitored for 30 days after implantation and will be assessed for all-cause mortality, the study’s primary endpoint. Safety and valve performance will continue to be assessed for 5 years at protocol-specified time points, as stated in the announcement. Details about the study are available on European Cardiovascular Research Center’s website.

According to the company, the Colibri TAVI system is a second-generation, investigational device that delivers premounted heart valves on balloon delivery catheters. The system is also precrimped, preloaded, and ready-for-use, and designed to reduce preparation time and eliminate the risk of malpositioned or damaged valves caused by crimping errors. The valves range in sizes from 21 to 30 mm. The company advised that the device is not currently available for sale in the United State or Europe.

Bernard Chevalier, MD, an interventional cardiologist at Hôpital Privé Jacques Cartier in Massey, France, is serving as Primary Investigator of the study. Didier Tchétché, MD, head of the structural heart disease program at the Clinique Pasteur hospital in Toulouse, France, also serves as an investigator and enrolled the first patients.

“I am proud to be a part of the Colibri Heart Valve study,” stated Dr. Tchétché. “This user-friendly system is ready for use with the valve already mounted on the balloon delivery catheter and packaged and sterilized. In simple terms, it goes from package to the patient.

“I found the system easy to use and valve performance, specifically the EOA (Effective Orifice Area of the aortic valve) is surprisingly extremely large with excellent sealing properties. This is an exciting next-generation valve. I look forward to continue enrolling.”