PARIS--(BUSINESS WIRE)--Cappella Medical Devices Ltd (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, is pleased to announce new long term follow up clinical data for its innovative Sideguard® coronary sidebranch system. This new data, to be announced this week, continues to validate the importance of protecting the ostium with the unique scaffolding design of the Sideguard® stent resulting in long term preservation of the coronary sidebranch.
Dr. Farzin Fath-Ordoubadi, Consultant Cardiologist and Cath Lab Director at Manchester Royal Infirmary who will be presenting one of the largest single centre experiences with the Sideguard® system commented, “We are delighted to present the most recent clinical data for the Cappella Sideguard® coronary sidebranch system. The Sideguard® data is exciting as not only does this dedicated device continue to challenge the current standard of practice for coronary bifurcation treatment but it also delivers a predictable and repeatable procedure by ensuring full coverage of the ostium of the sidebranch, maintaining wire access to the main vessel at all times, and protecting the sidebranch. These important advantages of the Sideguard® system have been validated with this follow-up data.”
Almost 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. Michael Gilmore, VP of R&D and Regulatory at Cappella, stated, “This emerging data demonstrates a safety profile at 6 months of 6.7% (n=254) including a sidebranch (SB) failure rate of 2.4% and a total bifurcation failure rate of 3.6% (SB, MB or SB and MB). This seems to compare favorably to the British Bifurcation Coronary (BBC1) study which demonstrates a safety profile at 9 months of 15.2% and 8% for the complex (n=250) and simple (n=250) techniques respectively while also demonstrating sidebranch and bifurcation failure rates of 1.2% and 5.2% respectively for the complex technique and 2.4% and 5.2% for the simple technique.”
Mr. Gilmore continued, “In addition, several studies this week demonstrate current bifurcation techniques often fail to scaffold the sidebranch ostium and result in a significant number of malapposed struts in the bifurcation segment. Malapposed struts increase the risk of late stent thrombosis and focal in-stent restenosis. In fact, the Sideguard® late (> 30 day and < 1year) stent thrombosis rate was only 0.3%. This data validates the unique advantages of the Cappella Sideguard® technology and we look forward to sharing more clinical results in the near future.”
About Cappella
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, 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.