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.
For more information:

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Overlay Init