Cappella Medical To Share Data Documenting Benefits Of Full Ostial Protection At EuroPCR 2011

Cappella, Inc. (Cappella), a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, today revealed how its innovative Sideguard® coronary sidebranch technology will be featured in several scientific sessions at this week's EuroPCR Congress in Paris, including a new European survey on the challenges in treating bifurcation disease.

Developed to protect the ostium of the sidebranch, the Cappella Sideguard coronary sidebranch technology offers interventional cardiologists a dynamic, effective, and easy-to-use solution in the treatment of bifurcation disease. This next generation stent platform preserves the sidebranch of diseased coronary arteries by protecting the ostium and minimising plaque shift. Cappella is currently engaged in a large-scale registry of more than 250 patients in Europe which should further confirm the ease of use and the reduced TVF rate.

Dr. Farzin Fath-Ordoubadi, Consultant Cardiologist and Cath Lab Director at the Heart Centre, Manchester Royal Infirmary commented, "Treating bifurcation disease has always been a challenge for physicians due to the complex anatomy of the coronary sidebranch. Conventional procedures forced us 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. Now with today's newer technology, such as the Cappella Sideguard system, we have a technology dedicated to bifurcation disease that scaffolds the ostium reducing plaque and carina shift while preserving the sidebranch. This offers a straightforward approach, minimising the technical limitations associated with conventional treatments. I am confident that dedicated bifurcation solutions will find a place in our practice going forward."

A recent survey carried out on behalf of Cappella Medical and published in the May/June edition of Coronary Heart magazine, invited clinicians across Europe to share their views on the challenges and opportunities for improvement in the treatment of bifurcation lesion treatment (BLT). David Blossom, Vice President of Commercial Operations at Cappella Medical, said of the results, "It was promising to learn that even though 82% of respondents most frequently used provisional stenting when treating bifurcation disease and an additional 13% used a mixture of the provisional and 2-stent approach, 95% of respondents were open to the idea of treating the sidebranch prior to the main artery." The survey revealed that clinicians were aware of the limitations of current practice with 83% reporting that up to 30% of provisionally stented patient's return for sidebranch treatment at which point they may not be able to regain access to the sidebranch. These procedures are costly, so it is clear that a 'get it right first time' approach is ideal. David commented, "This survey, added to the growing body of data being presented here at EuroPCR, reinforces our belief that the Sideguard system addresses a currently unmet need for the protection, and preservation, of the coronary sidebranch artery."

Several new studies have been released comparing the Cappella Sideguard technology to current practice. Dr. Akiko Maehara presented data recently showing that the self-expanding Cappella Sideguard stent is effective in maintaining an adequate lumen volume in the sidebranch and, especially, an adequate lumen area at the sidebranch carina at follow-up. In addition, the study also found that expansion of a balloon-expandable stent in the main vessel of a bifurcation lesion is associated with axial plaque redistribution that is not seen in the corresponding sidebranch treated with the self-expanding Cappella Sideguard stent, concluding that long-term follow-up will determine the impact of this phenomenon on ostial sidebranch restenosis. Dr. Nicolas Foin and colleagues from the Imperial College and Royal Brompton and Harefield NHS Trust, London, UK and the London Chest Hospital will be presenting results from a study comparing the treatment of bifurcations using Sideguard as a first line treatment compared to a conventional two-stent strategy. The study concludes that use of Sideguard appears to offer complete stent scaffolding at the sidebranch ostium while reducing strut malapposition at the bifurcation ostium. The clinical information being presented at EuroPCR continues to validate the unique advantages of the Cappella Sideguard technology. Cappella looks forward to sharing additional data in the coming months.

Source:
Cappella Medical Devices