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Positive Long Term Clinical Data of the Cappella Sideguard® Stent System Announced at TCT 2011

Wed, 11/09/2011 - 4:38am
SAN FRANCISCO--(BUSINESS WIRE)--Cappella Medical Devices Ltd (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, announced today at the 2011 TCT (Transcatheter Cardiovascular Therapeutics) Conference in San Francisco results from several long term studies of its Sideguard® technology. These studies document the need to treat coronary bifurcation disease with a dedicated sidebranch system versus the traditional provisional approach.

One study being presented this week includes the results of the Cappella Sideguard multicenter European Registry that included data on 125 patients from 9 institutions. This data was compared retrospectively to data from the current practice of provisional stenting in 125 bifurcations. The study concluded that sidebranch protection with the Sideguard device reduces sidebranch failure in comparison to provisional stenting. The investigators conclude that the Sideguard dedicated bifurcation stent could facilitate bifurcation PCI and make the procedure more predictable and safe. One of the investigators of the study from San Raffaele Scientific Institute in Milan, Italy, Dr. Azeem Latib, stated, "We are excited to share this data on the Sideguard technology documenting its benefits versus the existing provisional technique. Clinical data is important for any technology to be utilized and we look forward to building on this initial finding with ongoing trials to validate the need for dedicated bifurcation technology."

Another new study being presented this week is the long term follow up study of 61 patients from a single hospital (Manchester Heart Centre, Manchester, UK). This study concludes that the Sideguard system can be used to treat bifurcation lesions in a straightforward manner with excellent short and long term clinical outcomes. Dr. Farzin Fath-Ordoubadi, Consultant Cardiologist and Cath Lab Director at the Heart Centre, Manchester Royal Infirmary commented, "This study has shown that the Sideguard technology is not subject to some of the limitations associated with conventional bifurcation PCI techniques including the inability to fully cover the ostium of the sidebranch, maintaining wire access to the main vessel, and protecting the sidebranch at all times. The dedicated Sideguard system is a unique technology that overcomes limitations of other bifurcation treatment options." The data from these studies is expected to be published early next year.

Many patients have to return for a follow up PCI procedure for various reasons. Some of those reasons may be related to the fact that the sidebranch is not fully protected (including the ostium) during a conventional provisional bifurcation procedure. This lack of protection may result in plaque redistribution and/or carina shift that may necessitate the need for another procedure. Art Rosenthal, PhD, Executive Vice Chairman of the Board and President of Cappella R&D, stated, "Todays current techniques to treat bifurcation disease all have limitations in terms of ostial protection and sidebranch preservation. These studies are validating the need for a system designed specifically for the unique challenges of coronary bifurcations. We are confident that the positive results being presented this week at TCT are in part due to the Sideguard platform that scaffolds the ostium reducing plaque and carina shift while preserving the sidebranch."

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. Cappellas 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.

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