GALWAY, Ireland-- Cappella, Inc. (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, announced the start of Sideguard 3, an IVUS/OCT evaluation of the Sideguard® Coronary Sidebranch Stent & Delivery System. This is a European multicenter study to evaluate the vascular response to Sideguard in de novo bifurcation lesions of native coronary arteries. The primary objective of the study is to determine the change in stent area (mm2) and corresponding change in vessel area (mm2) at the carina of the sidebranch during the 6-month follow-up period.
“The results from the initial CE mark pivotal studies documented positive remodelling. The Sideguard 3 study is intended to provide further certainty for those findings.” said Gary S. Mintz. Further, Akiko Maehara, who also completed the analysis for the initial study said, “We are looking forward to having more clinical proof of the mechanisms of the remodelling process of nitinol in coronary stents.” Gary S. Mintz, MD, & Akiko Maehara, MD, Cardiovascular Research Foundation, New York, USA, are the co-PIs for the study.
One of the primary German investigators in the Sideguard 3 study and pioneer in dedicated sidebranch bifurcation stenting, Karl-Eugen Hauptmann, MD, Krankenhaus der Barmherzigen Brueder in Trier, Germany, stated, “Sideguard is my stent of choice for the treatment of bifurcation lesions. I am very happy to continue my close collaboration with Cappella in this interesting clinical trial.” Karl-Eugen Hauptmann has recently enrolled the first patients into the study.
About Cappella, Inc.
Cappella, Inc. is a medical device company, developing novel solutions for the treatment of complex Coronary Artery Disease (CAD) and specifically bifurcation vascular disease. Cappella’s initial product, the Sideguard® Coronary Sidebranch Stent & Delivery System offers interventional cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries first, rather than the main vessel. More importantly, it allows the preferred stent of choice for the main vessel. An optimal stent design specific to the anatomy of the sidebranch, combined with the qualities of nitinol now provide a dynamic solution for treating sidebranch disease. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, see: www.cappella-med.com.
Claire Marie Gigon
Cappella Medical Devices Limited
Tel: +41 (0) 79 374 57 65