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 the multicenter long term follow up results for its innovative Sideguard® coronary sidebranch stent . Long term follow up data on the Sideguard stent was obtained from 399 patients from the United Kingdom, Germany, and Italy. The MACE rate was: 3.7% (30 day F/U), 7.1% (6 mo F/U) and 10.2% (1 year F/U) comparing favourably with existing standard practice.
This data represents the largest multicenter clinical experience 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 multicenter experience have confirmed that preservation of the sidebranch of diseased coronary arteries by protecting the ostium has clear long term benefits when compared to existing standard practice of provisional and two-stent procedures.
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 long term follow up data from this multicenter study validate the fact that a dedicated bifurcation technology that protects the ostium of the sidebranch is a viable alternative to the more traditional provisional and two stent strategies when treating coronary sidebranch disease.”
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. Gary Brogan, VP of Regulatory and Clinical Affairs at Cappella, stated, “Up until now, physicians have been forced 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. The provisional and two-stent techniques used today all involve manipulating the straight DES stent struts in an attempt to provide clear access into the sidebranch. Data is now being presented documenting the negative flow dynamic and shear stress issues of floating stent struts. We are confident that these positive results are due to the Sideguard platform that scaffolds the ostium reducing plaque and carina shift while preserving the sidebranch. This long term follow up data validates the unique advantages of the Cappella Sideguard technology even when compared to existing DES treatment options.”
About Cappella Medical Devices
Cappella, Inc. is a medical device company that develops novel solutions for the treatment of complex coronary artery disease (CAD) and peripheral artery disease (PAD) focused on its flagship Sideguard technology platform. Cappella’s Sideguard® coronary sidebranch technology offers clinicians 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, South America, India, and Canada. 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.