October 1, 2018
BROOMFIELD, CO – September 19, 2018 – 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 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting taking place September 21-25, 2018 in San Diego, CA. 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. Details may also be available at the Colibri exhibit booth #2148.
Dr. Fish stated, “The post-implantation measures of aortic valve pressure gradients and paravalvular leakage continue to be favorable at six months following implantation. We look forward to providing detailed findings at TCT and confirming these results in a larger CE Mark study, which will be an important step towards commercialization.”
The EFS of patients with severe aortic stenosis has completed enrollment. Colibri’s 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. The Colibri TAVI System is being developed with 21mm, 24mm, 27mm and 30mm valves to accommodate a variety of clinical and patient needs.
“The second-generation valve system tested in this EFS was designed to offer superior valve performance and the flexibility to treat different types of patients while mitigating the risk of 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 have elected to advance our TAVI system directly into a CE Mark study that we expect to commence by the end of the year.”
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 valveimplantation (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.
Corporate and Media Relations Contact:
Joseph B. Horn, CEO Colibri Heart Valve LLC Telephone: (303) firstname.lastname@example.org