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: www.colibrihv.com
 

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init