Cappella initiates multi-center Italian Sideguard open label clinical study

Feb 1 2011

Cappella Medical Devices announces initiation of the multi-center Italian Sideguard^® open label clinical study. The Principal Investigator (PI) of the study, Dr. Giuseppe Massimo Sangiorgi at the Policlinico di Modena - University of Modena and Reggio Emilia, in Modena, Italy stated, "The side branch ostium anatomy requires a unique technology solution to effectively manage and optimize treatment. The shape and elastic properties of the nitinol Sideguard stent provide constant outward radial force on the lumen and ostium providing support and protection of the side branch over time and hopefully reducing neointimal proliferation at the ostium of the side branch in the long term follow-up. The Sideguard system is an easy-to-use solution for treating bifurcation disease and we are looking forward to being part of this study."

“It is clear that the engineering approach Cappella has taken to design a stent technology tailored to the geometry and mechanics of the ostium will be validated by objective clinical evidence.”

This study represents Cappella's ongoing commitment to documenting the clinical benefits of Sideguard for side branch preservation as primary intervention for managing bifurcation related disease. Similar open label studies are also underway in UK, Germany and South America.

Cappella has also recently concluded an IVUS/OCT study designed to further demonstrate the mechanistic benefits of ostial protection and positive remodeling to minimize side branch luminal narrowing. The exciting results of a partial analysis will be presented in part at the upcoming JIM (Joint Interventional Meeting) in Rome, Italy by Dr. Akiko Maehara. Full study results will be presented at the upcoming EuroPCR cardiology meeting in Paris this coming May. Cappella Inc. CEO, Art Rosenthal, Ph.D added, "It is clear that the engineering approach Cappella has taken to design a stent technology tailored to the geometry and mechanics of the ostium will be validated by objective clinical evidence."

SOURCE Cappella, Inc.