BROOMFIELD, CO, May 13, 2014 (GLOBE NEWSWIRE) -- Colibri Heart Valve, LLC, a privately held emerging medical device company, today announced that Dr. Bernard Chevalier will present long-term findings on patients enrolled in the Company's first-in-human study of its proprietary 24mm transcatheter aortic valve implantation (TAVI) system at the upcoming annual meeting of the European Association for Percutaneous Cardiovascular Interventions taking place May 20-23 in Paris, France. The patients enrolled in the study demonstrated consistent positive outcomes including no observed stroke, no pacemaker implantations, virtually no paravalvular leak (PVL), and a high retained average effective orifice area (EOA) of 2.2 cm2 up to 18 months post implantation.
"We are honored to have Dr. Bernard Chevalier, an expert in interventional cardiology and transcatheter heart valve replacement, present an update on the competitive long-term clinical data demonstrated in the Colibri feasibility study at the upcoming EuroPCR meeting," stated Joseph B. Horn, Colibri's president and chief executive officer. "The impressive and consistent long-term clinical outcomes are directly related to the design features of the Colibri TAVI system which uses a proprietary leaflet design that optimizes opening and closing valve behavior. In addition, Colibri's low profile, tri-axial, 9Fr delivery catheter, which is loaded and delivered through a 14Fr sheath, provides enhanced trackability to navigate tortuous anatomies such that the catheter does not need a deflection device. The low profile and improved trackability of the Colibri TAVI System may be of significance in patients with small femoral arteries or with acute angulations of the aortic arch. We look forward to confirming these exciting results 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 upcoming EuroPCR meeting. Colibri's presentation will be part of the "New Aortic Devices" panel that is being held on Wednesday, May 21 from 08:15-10:15 in the Room Maillot.
For more information on the Colibri TAVI System 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 booth (# M24) during the EuroPCR 2014 meeting.
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.
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.
CONTACT: Eric Schauble, VP, Corporate Development Colibri Heart Valve, LLC Telephone: (303) 460-8667 firstname.lastname@example.org Aline Schimmel Scienta Communications Telephone: (312) 238-8957 email@example.com
Source:Colibri Heart Valve, LLC