Colibri Heart Valve announced that patient enrollment has concluded in the first-in-human study of the Company's transcatheter aortic valve implantation (TAVI) system in the Dominican Republic trial site.
Analysis of the data from patients enrolled in this site yielded clinical outcomes that met the study’s endpoints.
Colibri will provide a clinical update on the first-in-human study at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference taking place in San Francisco October 27 – November 1, 2013.
The Colibri TAVI system (US Patent 8,361,144) is the world’s first and only low profile, 14 French pre-mounted, pre-crimped, and pre-packaged, ready-for-use TAVI system.
Center of Advanced Medicine (CEDIMAT) in Santo Domingo, Dominican Republic director of the cardiovascular department and primary investigator of the Colibri clinical studyDr Pedro Urenya said:"We have observed a preserved aortic valve area (AVA) of 2.0 to 2.3 cm2 in these patients, which is atypically high for TAVI devices. This suggests that the Colibri proprietary valve design may improve valve performance, which in turn could potentially improve clinical benefit."
Colibri president and chief executive officer Joseph B. Horn said the proprietary folded valve design of the Colibri valve maximizes functionality while minimizing profile and has produced impressive clinical results to date.
"We are looking forward to the next phase of development, in which we expect to commence a study by the end of 2014 to support a CE Mark application," Horn added.
Colibri will have two presentations at the upcoming 25th Annual TCT Conference, the first being Dr Bernard Chevalier’s podium presentation titled "The Colibri TAVR System."
This presentation is part of the "Aortic Valve Therapies: Today and Tomorrow: Part II" session on Monday, October 28 that begins at 8:00am local time. Dr. Chevalier’s presentation will begin at 4:23pm. Dr. Chevalier is an attending cardiologist at the Institut Cardiovasculaire Paris-Sud and a member of the Colibri scientific advisory board.
In addition, Dr. David Paniagua will be presenting "First Human Transcatheter Aortic Valve Implantation of the Colibri Heart Valve, a Pre-mounted, Pre-packaged, Low Profile Ready for Use, Dry Valve in a 14 French Delivery System; Six Months Follow up" in the oral abstract session taking place on Tuesday, October 29 at 2:57pm.
Dr. Paniagua is a co-founder of Colibri and an assistant professor of medicine in the Baylor College of Medicine Section of Cardiology.