Colibri Heart Valve to Present One-Year Patient Follow-Up Results from Clinical Feasibility Study of Second-Generation TAVI System at EuroPCR
BROOMFIELD, CO , May 14, 2019 (GLOBE NEWSWIRE) -- Colibri Heart Valve LLC, a privately held emerging medical device company, today announced that results from the company’s international, single-arm, open-label early feasibility study (EFS) of the Colibri transcatheter aortic valve implantation (TAVI) system will be presented at the upcoming EuroPCR annual meeting taking place May 21-24, 2019. One-year follow-up data from the five evaluable patients, two of whom received a 27mm valve and three a 24mm valve, will be presented by R. David Fish, MD, FACC, FSCAI, Colibri’s founder and chief medical officer, on May 23rd in Room 353. Details will also be available at the Colibri exhibit booth #M15.
“The post-implantation measures of aortic valve pressure gradients and paravalvular leakage continue to be favorable at one year following implantation. We look forward to providing detailed findings at EuroPCR,” stated Dr. Fish. “We aim to confirm these results in a larger CE Mark study, which will be an important step towards commercialization. The company expects to commence the CE Mark study in the summer of 2019.”
The early feasibility study of patients with severe aortic stenosis completed enrollment in April 2018. Colibri’s proprietary TAVI system features a replacement heart valve pre-mounted and pre-crimped on a balloon delivery catheter. The valve and balloon are pre-loaded into a low-profile access sheath and the system is supplied sterilized in a ready-for-use form. The Colibri TAVI System is being developed with 21mm, 24mm, 27mm and 30mm valves to accommodate a variety of clinical and patient needs. Overall, the data show consistency at the various time points through one-year follow-up.
“The second-generation valve system tested in this EFS was designed to go from package to patient and offers superior valve performance with the goal to mitigate patient-prosthetic mismatch (PPM),” added Joseph B. Horn, Colibri’s president and chief executive officer. “Following the extremely positive outcomes of patients in our EFS, we look forward to beginning our CE Mark study.”
About the Colibri Heart Valve and the Ready-for-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 and July 10, 2004. 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.
CONTACT: John Dunn Colibri Heart Valve LLC Telephone: (303) 460-8667 jdunn@colibrihv.com Aline Sherwood Scienta Communications Telephone: (312) 238-8957 asherwood@scientapr.com
