LOUISVILLE, CO , Nov. 03, 2021 (GLOBE NEWSWIRE) -- Colibri Heart Valve LLC, a privately held emerging medical device company, today announced the initiation of an international pilot study of the Colibri transcatheter aortic valve implantation (TAVI) system. Bernard Chevalier, M.D., an interventional cardiologist at Hôpital Privé Jacques Cartier, is serving as primary investigator of the study. The study involves enrolling patients with severe aortic stenosis who are at high surgical risk. The first patients treated in this pilot study were enrolled in Toulouse, France. Additional study sites are expected to open later this year in the UK.
“While our clinical development plans were initially suspended due to the Covid-19 pandemic, we were able to resume our discussions earlier this year with regulatory agencies. Our first clinical sites are open and we expect additional sites to begin enrolling patients in the coming weeks,” explained Joseph B. Horn, Colibri’s president and chief executive officer.
Didier Tchétché, M.D., the head of the structural heart disease program at the Clinique Pasteur hospital in Toulouse, France, is an investigator in the CE Mark-enabling pilot study and enrolled the first patients. Commenting on his experience, Dr. Tchétché stated, “I am proud to be a part of the Colibri Heart Valve study. 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.”
Colibri’s pilot study is employing a second-generation TAVI system that is designed to deliver a valve with superior performance in a range of sizes from 21mm to 30mm in order to potentially mitigate the risk of patient-prosthetic mismatch (PPM). The Colibri heart valves are pre-mounted on balloon delivery catheters to reduce preparation time and eliminate the risk of malpositioned or damaged valves caused by crimping errors.
"The specific features of this novel transcatheter heart valve including the dry tissue and leaflet design, allowed us to demonstrate larger orifice areas, as seen in the above results, compared to benchmarks. We will look to confirm these findings during the early phase of the ongoing pilot study,” explained Dr. Chevalier. “I’m looking forward to working with Dr. Tchétché and our European investigators as well as the team at Colibri, as we continue to advance this TAVI system.”
Patients in the ongoing pilot study will be monitored for 30 days following implantation and assessed for all-cause mortality, the study’s primary endpoint. Safety and valve performance will continue to be assessed for five years at protocol-specified timepoints. Should results from this pilot study confirm earlier clinical findings, Colibri is prepared to initiate a CE-Mark registrational study. Patients and referring physicians interested in learning more about the study may find details on the Centre Europeén de Recherche Cardiovasculaire S.A.S (CERC) website.
About Colibri Heart Valve
Colibri Heart Valve LLC is a privately held medical device company that researches and develops novel, patent protected, structural heart technologies. Colibri’s proprietary technology is protected by both trade secrets and issued and pending patent applications. The Colibri TAVI System is an investigational device and is not currently available for sale in the USA or EU. For more information, visit: www.colibrihv.com.
About Colibri’s Ready-for-Use Colibri TAVI System
Through Colibri’s 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.” Colibri’s advanced technology is a culmination of over 15 years of research and development into transcatheter heart valve technology. Colibri’s unique tissue processing method produces extremely strong, durable, and biocompatible tissue. The proprietary tissue enables loading, crimping, and packaging of the Colibri valve at manufacture, making in-procedure valve rinsing and loading at time of use unnecessary.
