Colibri Heart Valve Advances Second-Generation TAVI System into Clinical Feasibility Study

Colibri Heart Valve LLC, a privately held emerging medical device company, announced that the first two patients have been successfully enrolled in a clinical early feasibility study (EFS) of the company’s disruptive second-generation ready-for-use balloon-expandable transcatheter aortic valve implantation (TAVI) system.
 
As with Colibri’s earlier generation system, this TAVI system contains a replacement aortic heart valve that is pre-mounted, and pre-crimped on a balloon delivery catheter, loaded into a low-profile access sheath and sterilized, ready-for-use from package to patient. The company’s second-generation TAVI system includes enhancements to address a wider range of patient candidates including those with bicuspid aortic valves.
 
“This TAVI system features superior functionality and design elements that allow for improved valve performance and accurate valve placement, and the ready-for-use nature of the Colibri TAVI System provides an ease of use that is unique in the marketplace today,” explained Dr. David Fish, Colibri’s chief medical officer, founder, and an investigator of the EFS.
 
Two patients with severe aortic stenosis were enrolled as part of Colibri’s EFS, an international prospective, non-randomized, single-arm, open-label trial to assess early feasibility of the Colibri 24 mm and 27 mm percutaneous aortic heart valve and delivery system. The two patients were successfully treated with a 27 mm Colibri TAVI System and demonstrated post-implantation single digit mmHg mean aortic valve pressure gradients and no observed paravalvular leakage (PVL) or aortic insufficiency (AI). Enrollment in the ongoing clinical study of the Colibri TAVI System in up to 10 patients is taking place and is expected to yield 30-day follow-up data which will be presented at an upcoming medical conference.
 
As patients at low and intermediate surgical risk and those with bicuspid disease, especially younger patients, are increasingly becoming candidates for TAVI over surgical valve implantation, (Hamm et al. 2016) the availability of transcatheter heart valves with improved valve function and durability will become more critical to long-term success.
 
Joseph B. Horn, Colibri’s president and CEO concluded, “Colibri’s technology has been developed to address market challenges in the evolving and expanding TAVI space and the EFS results to date successfully confirm our design considerations. Our engineering team has made significant strides to optimize the Colibri TAVI System and we are now in a position to address the challenging needs in the marketplace. Following the completion of our EFS study, we look forward to furthering the clinical development of our current generation TAVI system and anticipate moving quickly into a larger regulatory approval study this calendar year.”
 
Colibri Heart Valve LLC is a privately held medical device company that researches and develops patent protected, structural heart technologies. Colibri was formed in 2010 and is located near Boulder, Colo. 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 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 Jan. 4, 2002.