Colibri Heart Valve has announced that the first two patients have been successfully enrolled in a clinical early feasibility study of its second-generation ready-for-use balloon-expandable transcatheter aortic valve implantation (TAVI) system.
As with Colibri’s earlier generation system, a press release reports, 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 sterilised, ready-for-use from package to patient.
According to the press release, the company’s second-generation TAVI system includes enhancements to address a wider range of patient candidates including those with bicuspid aortic valves.
Two patients with severe aortic stenosis were enrolled as part of Colibri’s study, an international prospective, non-randomized, single-arm, open-label trial to assess early feasibility of the Colibri 24mm and 27mm percutaneous aortic heart valve and delivery system. The two patients were successfully treated with a 27mm Colibri TAVI system and demonstrated post-implantation single digit mmHg mean aortic valve pressure gradients and no observed paravalvular leakage or aortic insufficiency (AI). Enrolment 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.
David Fish, Colibri’s chief medical officer, founder, and an investigator of the early feasibility study, says: “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.”
Joseph B Horn, Colibri’s president and chief executive officer comments: “Colibri’s technology has been developed to address market challenges in the evolving and expanding TAVI space and the early feasibility study results to date successfully confirm our design considerations. Our engineering team has made significant strides to optimise the Colibri TAVI system and we are now in a position to address the challenging needs in the marketplace. Following the completion of our early feasibility 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.”