Colibri Heart Valve Continues Enrollment in Clinical Feasibility Study of Second-Generation TAVI System
May 4, 2018BROOMFIELD, CO – May 4, 2018 – Colibri Heart Valve LLC, a privately held emerging medical device company, today announced that the Colibri transcatheter aortic valve implantation (TAVI) System has been used on an additional four patients in the ongoing international, single-arm, open-label early feasibility study (EFS). Initial post-implantation results from these patients, who received a 24mm valve, show favorable low aortic valve pressure gradients and no observed paravalvular leakage or aortic insufficiency. The Colibri TAVI System is being developed with 21mm, 24mm, 27mm and 30mm valves to accommodate a variety of clinical and patient needs.
Thirty-day follow-up results from these patients as well as from those implanted with the Colibri 27mm valve in March, will be available at the Colibri Heart Valve Exhibit booth at the EuroPCR 2018 in Paris, France from May 22-25, 2018. More information on Colibri’s presence at EuroPCR can be found on the company’s Events webpage.
“The outcomes of patients who received the 24mm valve are consistent with our experience to date with the 27mm valve,” commented Dr. David Fish, Colibri’s chief medical officer, founder, and an investigator of the EFS. “Enrollment of patients in the EFS with a second size of the Colibri TAVI System is an important milestone for the Company. The consistency in the clinical results demonstrated through the enrollment of patients receiving multiple sizes of the Colibri TAVI System, soon to be complimented with the addition of a 21mm and 30mm size, demonstrate the scalability in the Colibri valve and TAVI System design.”
The ongoing EFS will enroll up to 10 individuals with severe aortic stenosis, who will be implanted with Colibri’s second-generation 24mm or 27mm percutaneous aortic heart valve in a TAVI procedure. This proprietary TAVI system features a replacement heart valve pre-mounted and pre-crimped on a balloon delivery catheter, pre-loaded into a low-profile access sheath and sterilized, ready-for-use from package to patient. To track the progress of this study, please visit the Milestone webpage on www.ColibriHV.com.
“This is an exciting time for Colibri as the significantly differentiating products we are bringing to the clinic are the embodiment of our founder’s vision and associated patent portfolio dating back to 2002,” added Joseph B. Horn, Colibri’s president and chief executive officer. “With the patented Colibri folded leaflet technology, our 27mm valve on average, demonstrated an aortic valve area of over 3.0 cm2 and a single-digit valve gradient. This represents a significant improvement in clinical performance in the heart valve marketplace and will alleviate the patient prosthetic mismatch (PPM) that is observed with currently available heart valves.”
About the Colibri Heart Valve and the Ready-to-Use Colibri TAVI System
Colibri Heart Valve LLC is a privately held medical device company that researches and develops novel, patent protected, structural heart technologies. Colibri was formed in 2010 and is located near Boulder Colorado. 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. The Colibri technology is protected by both trade secrets and issued and pending patent applications with priority claims and content dating back to January 4, 2002. For more information, visit: www.colibrihv.com.
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