News | October 25, 2013

Colibri Heart Valve Concludes Patient Enrollment in First-in-Human Study of TAVI System

Findings to be Presented at Upcoming 25th Annual Transcatheter Cardiovascular Therapeutics Scientific Conference

heart valve repair clinical trial study colibri tavi TCT
October 25, 2013 — Colibri Heart Valve LLC, a medical device company, 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 Oct. 27-Nov. 1 in San Francisco. The patented Colibri 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.
"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," stated Dr. Pedro Urenya, primary investigator, Colibri clinical study and director, cardiovascular department, Center of Advanced Medicine (CEDIMAT) in Santo Domingo, Dominican Republic.
"The proprietary folded valve design of the Colibri valve maximizes functionality while minimizing profile and has produced impressive clinical results to date,” said Joseph Horn, Colibri's president and CEO. “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."
Colibri will have two presentations at the upcoming 25th Annual TCT Conference, the first being a podium presentation titled "The Colibri TAVR System" by Dr. Bernard Chevalier, attending cardiologist, Institut Cardiovasculaire Paris-Sud and member, Colibri scientific advisory board. The presentation is part of the "Aortic Valve Therapies: Today and Tomorrow: Part II" session on Monday, Oct. 28.
In addition, Dr. David Paniagua, founder, Colibri and assistant professor of medicine, Baylor College of Medicine Section of Cardiology, 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, Oct. 29.
The Colibri Heart Valve will be in booth 1139 during the TCT 2013 meeting.
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