Broomfield, CO — September 12, 2014
Colibri Heart Valve, LLC, a privately held emerging medical device company, today announced that long-term results on patients enrolled in the Company’s first-in-human study of its proprietary 24mm transcatheter aortic valve implantation (TAVI) system will be presented by Dr. Bernard Chevalier at the upcoming Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference taking place in Washington DC September 13-17th. The patients enrolled in the study continue to demonstrate consistent positive outcomes including no observed stroke, no pacemaker implantations, virtually no paravalvular leak (PVL), and a high retained average effective orifice area (EOA) >2.2cm2 now confirmed by multiple patients with greater than one year follow up completed.
“Dr. Bernard Chevalier is a valued advisor to Colibri and an expert in interventional cardiology and transcatheter heart valve replacement, and we are honored by his continued commitment to Colibri’s development efforts,” stated Joseph B. Horn, Colibri’s president and chief executive officer. “We believe that the impressive data observed to date suggests that the Colibri technology, an off-the-shelf, ready-for-use, aortic heart valve, can be competitive clinically and will provide physicians with a simpler and time-saving preparation method. We look forward to confirming the consistent long-term clinical outcomes observed to date in a larger clinical study in support of a CE Mark application.”
Dr. Bernard Chevalier, an attending cardiologist at the Institut Cardiovasculaire Paris-Sud and a member of the Colibri scientific advisory board will present the update on the Colibri TAVI system at the TCT meeting next week. Colibri’s presentation will be part of the didactic symposia titled “Aortic Valve Therapies – Today and Tomorrow III, Early Stage New TAVR Systems” that is being held on Monday, September 15 from 04:05-4:50 in the Room 202A/B.
For more information on the Colibri TAVI System’s differentiated design features and clinical update on first-in-human feasibility study of the first ready-to-use transcatheter heart valve system please visit the Colibri Heart Valve website at www.colibrihv.com.
About the Colibri Heart Valve and the Ready-to-Use Colibri TAVI System
Colibri Heart Valve, LLC is a privately held medical device company based in Broomfield, CO that researches and develops novel heart valve technologies. Colibri has developed a pre-mounted, pre-crimped, and pre-packaged, ready-for-use transcatheter aortic valve implantation (TAVI) device called the “Colibri TAVI System.” The TAVI procedure is an important treatment option for heart valve replacement due to its minimally invasive nature, clinical efficacy, extensive patient experience, and reduced procedural costs. Colibri’s advanced technology is a culmination of over 10 years of research and development by Colibri’s founders, Dr. David Paniagua and Dr. R. David Fish into the tissue, valve design, frame, and delivery catheter. Colibri’s unique tissue processing method produces extremely strong, durable, and biocompatible tissue. The proprietary tissue enables loading, crimping, and packaging of the Colibri valve at manufacture, making in-procedure valve rinsing and loading at time of use unnecessary. The “Colibri TAVI System” is designed to be shipped ready-for-use and will be available in multiple sizes. 2
Colibri’s corporate headquarters and pre-commercialization facilities are located in Broomfield, Colorado with R&D located in Houston, Texas. For more information, visit: www.colibrihv.com.