News | April 12, 2013

First Clinical Implant of Colibri Transcatheter Aortic Heart Valve Reported

Colibri Heat Valve TAVI System Clinical Trail Heart Valve Repair

April 12, 2013 — Colibri Heart Valve LLC 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. These advantages are designed to reduce delivery profile along with a reduction in preparation and insertion time, which are not available in any other device, either currently available or in known development.

"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."

Dr. Pedro Urenya, 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 her aortic valve. Urenya was observed by Colibri's scientific founders, doctors. 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 anesthesia, 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, multicenter, non-randomized, investigational study to assess the safety, technical feasibility and deployment characteristics of the 24 mm Colibri aortic heart valve and delivery system. Enrollment in the ongoing clinical study of the Colibri TAVI system in up to 10 patients is taking place at multiple trial sites outside the United States and is expected 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.

For more information, visit: www.colibrihv.com

Related Content

Boston Scientific, Edwards Lifesciences Agree To Global Litigation Settlement
News | Heart Valve Technology | January 15, 2019
Boston Scientific Corp. and Edwards Lifesciences Corp. announced that the companies have reached an agreement to settle...
The implantation of a MitraClip is guided under live transesophageal echo (TEE). This image shows the operator moving the open clip into position and engaging the mitral valve leaflets. The clip appears as a arrowhead shape in the ultrasound with the leaflets coming off each side. Photo from a MitraClip procedure at the University of Colorado Hospital. Dr. Dominick Wiktor. The TEE is from a Philips Epiq system.

The implantation of a MitraClip is guided under live transesophageal echo (TEE). This image shows the operator moving the open clip into position and engaging the mitral valve leaflets. The clip appears as an arrowhead shape in the ultrasound with the leaflets coming off each side. Photo from a MitraClip procedure at the University of Colorado Hospital.

Feature | Heart Valve Technology | January 14, 2019 | Allen Atchley, M.D., FACC, The Chattanooga Heart Institute
Mitral regurgitation (MR) is one of the most common types of heart valve diseases in the United States, affecting app
JC Medical Announces First U.S. Treatment With J-Valve TAVR Device
News | Heart Valve Technology | January 07, 2019
January 7, 2019 — JC Medical announced the successful treatment of the first U.S.
Edwards' Sapien 3 Ultra Transcatheter Heart Valve Receives FDA Approval
Technology | Heart Valve Technology | January 02, 2019
Edwards Lifesciences Corp. announced that the Sapien 3 Ultra system has received U.S. Food and Drug Administration (FDA...
Boston Scientific Prevails in U.S. Edwards Lifesciences Litigation
Feature | Heart Valve Technology | December 12, 2018
A jury in the U.S. District Court for the District of Delaware determined Dec. 11 that the Boston Scientific U.S....
First TriCinch Coil Tricuspid Repair Systems Implanted in U.S.
News | Heart Valve Technology | November 06, 2018
4Tech Inc. initiated its U.S. Early Feasibility Study of the TriCinich Coil System following U.S. Food and Drug...
Valve Replacement Volume Key to Successful Patient Outcomes
News | Heart Valve Technology | November 02, 2018
Hospitals that routinely perform a heart valve replacement procedure requiring open heart surgery are more likely to...
Prosthetic Valve Mismatches Common in TAVR Procedures
News | Heart Valve Technology | October 03, 2018
A high number of patients in a study who underwent transcatheter aortic valve replacement (TAVR) experienced severe and...
Local Anesthesia Safe and Effective for Intermediate- and High-Risk TAVR Patients
News | Heart Valve Technology | September 28, 2018
The first randomized study to compare general versus local anesthesia during transcatheter aortic valve replacement (...
Overlay Init