GALWAY, Ireland--(BUSINESS WIRE)--Cappella Medical Devices Ltd (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, today announced initial long term follow up data for its innovative Sideguard® coronary sidebranch stent from Manchester Royal Infirmary in Manchester, United Kingdom. Long term follow up data on the Sideguard stent was obtained from 38 patients that received the stent as early as March 2010. The stent was successfully placed in all 38 patients. There were no peri-procedural complications and MACE rates were 5.3% at 1 year follow up.
This initial data represents one of the largest single-center clinical experiences to date with the Sideguard technology. The Sideguard was developed to protect the ostium of the sidebranch offering interventional cardiologists a dynamic, effective, and easy-to-use solution in the treatment of bifurcation disease. Results from this single center experience confirmed that preservation of the sidebranch of diseased coronary arteries by protecting the ostium has short and long term benefits.
Dr. Farzin Fath-Ordoubadi, Consultant Cardiologist and Cath Lab Director at the Heart Centre, Manchester Royal Infirmary commented, “The Sideguard stent can be used to treat complex bifurcation lesions in a straight forward manner, with excellent clinical outcomes. The one year MACE rate of 5.3% validates the fact that a dedicated bifurcation technology that protects the ostium of the sidebranch and preserves the sidebranch is, and will be, an ideal solution for patients with true bifurcation disease.” This exciting data is corroborated by the early data coming from the real world, multi centre Sideguard One Registry. The data coming from this registry on 250 patients treated with the Sideguard device is expected to be published early next year.
Up to 30% of all PCI patients have bifurcation disease yet there has not been one proven dedicated treatment solution. Treating these patients has always been a challenge for physicians due to the complex anatomy of the coronary sidebranch. Dr. Art Rosenthal, Executive Vice Chairman and President of R&D, stated, “Conventional procedures forced physicians to treat the bifurcation with either two stents that weren’t intended for this use, or one main vessel stent that has limitations in terms of ostial protection and sidebranch preservation. MACE for existing bifurcation solutions have been documented to be 8% in the BBC-ONE study, so this initial long term MACE of 5.3% with the Sideguard is very encouraging. We are confident that these positive results are in part due to the Sideguard platform that scaffolds the ostium reducing plaque and carina shift while preserving the sidebranch. This data validates the unique advantages of the Cappella Sideguard technology. Additional long term follow up clinical data including interim results of the full multi-center Sideguard registry, of which Manchester Royal Infirmary is part of, will be presented over the next several months.”
About Cappella Medical Devices
Cappella, Inc. is a medical device company that develops novel solutions for the treatment of complex coronary artery disease (CAD) focused on protecting the coronary sidebranch arteries. Cappella’s Sideguard® coronary sidebranch technology offers interventional cardiologists a straightforward, effective, and easy to use solution that preserves the sidebranch of diseased coronary arteries by protecting the ostium while minimizing plaque shift. The Sideguard delivery system features a proprietary split-sheath, balloon released, technology that ensures precise placement on the ostial borderline. The Sideguard self-expanding, nitinol, stent promotes continuous wall apposition and positive remodelling and its unique trumpet-shaped design conforms to varying characteristics of the sidebranch ostium. The Cappella Sideguard system is currently CE mark approved and is being distributed throughout Europe and South America. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, please visit the Cappella Medical Systems website at www.cappella-med.com.
David Blossom, +353 (0) 91 758 939