Brussels, Belgium (PRWEB) August 16, 2007
Cardiatis, SA announced today that it has completed recruitment of patients into its first-in-man European clinical trial of its 3D Multilayer Braided Stent for repairing aneurysms.
Patient recruitment, which began in December 2006, culminates four years of extensive concept testing that demonstrated the ability of the 3D multilayer stent to repair aneurysms endovascularly without need for coils or stent grafts.
"The spatial three-dimensional design of the multilayer stent slows and laminates blood flow within the aneurysm minimizing chances of aneurysm rupture and allowing an organized thrombus to form" stated Patricia Gruffaz, Cardiatis Head of Research & Development.
Extensive pre-clinical tests including theoretical simulation utilizing Computerized Fluid Dynamics (CFD), Lattice Boltzmann, and Molecular Modelization methods, in-vitro modeling using Particle Image Velocimetry (PIV) methods as well as a complete in-vivo testing program of different animal aneurysm models have all demonstrated the soundness and feasibility of the fluid dynamic modulation concept for endovascular aneurysm repair.
"Entering this final stage of patient recruitment is an important milestone for Cardiatis and we are very grateful to the patients and their physicians involved in this trial." stated Noureddine Frid, Cardiatis President. "With the completion of patient recruitment behind us, we can now look forward to a CE filling before the end of this year."
Cardiatis, an innovative medical technology company located in Belgium, is focused on developing its patented FluidSmart 3D multilayer stent technology platform, a next generation technology for endovascular aneurysm repair. Additional information can be found on Cardiatis web site at http://www.cardiatis.com.