Colibri Heart Valve, LLC has announced that it has successfully completed the first clinical use of the company’s proprietary transcatheter aortic heart valve. The Colibri transcatheter aortic valve implantation (TAVI) system is the world’s first and only low profile, 14 French pre-mounted, pre-crimped, and pre-packaged, ready-for-use, TAVI system.
The system is designed to reduce delivery profile along with a reduction in preparation and insertion time which are not available in any other device currently.
“The successful first-in-patient implantation of this breakthrough TAVI system is a significant and exciting milestone for our company,” stated Joseph B. Horn, Colibri’s president and chief executive officer. “While there have been many advancements in TAVI technology in recent years, we believe the advantages offered to physicians and hospitals by the Colibri TAVI system have the potential to measurably simplify and reduce pre-procedure preparation time and therefore overall cost. In addition, we believe the low profile 14 French introducer used in our system has the potential to be used in patients not currently considered TAVI candidates due to the relatively small diameter of their femoral arteries, thereby increasing the number of TAVI femoral patients who may benefit from this procedure.”
Pedro Ureña, the director of the Cardiovascular Department at the Center of Advanced Medicine (CEDIMAT) in Santo Domingo, Dominican Republic, performed a procedure last week on a female patient with extensive calcification of the aortic valve. Ureña was observed by Colibri’s scientific founders, R David Fish and David Paniagua.
Commenting on his first-hand experience with Colibri’s TAVI system, he said: “I was very impressed with the ease and speed with which my team and I were able to implant the Colibri valve. The time from removing the valve from its sterile package to valve deployment was much shorter than with other TAVI systems. The fact that the valve arrived ready to use, crimped and mounted on the delivery catheter greatly reduced our preparation time, an important convenience when performing a procedure as complex as a TAVI procedure. The relatively short pre-procedure requirement also reduced the time the patient was under anaesthesia, an important factor for high risk patients, and allowed my staff to devote more time to patient care.”
This patient was treated as part of Colibri’s first-in-human feasibility study, an international prospective, multicentre, non-randomised, investigational study to assess the safety, technical feasibility, and deployment characteristics of the 24mm Colibri aortic heart valve and delivery system. Enrolment in the ongoing clinical study of the Colibri TAVI system is up to 10 patients and is taking place at multiple trial sites outside the USA and is expected, according to the company, to yield 30-day follow-up data by the end of the first quarter of 2013. To be eligible for the study, individuals must have severe symptomatic aortic valve stenosis and be very high risk for open-heart valve replacement surgery. Study participants will be monitored at 30 days and one year following implantation.