Feb 11 2011
Cappella Medical Devices presented new clinical data on its unique Sideguard® coronary sidebranch system today at the International JIM 2011 (Joint Interventional Meeting) in Rome, Italy. The new study titled Bifurcation Plaque Redistribution: An Intravascular Ultrasound Comparison of the Self-expanding Sideguard® Stent in the Sidebranch Versus a Balloon-Expandable Stent in the Main Vessel was presented by a group of investigators led by Gary Mintz, MD (Colombia University Medical Center/Cardiology Research Foundation, New York, NY).
“Expansion of a balloon expandable stent in the main vessel of a bifurcation lesion was associated with axial plaque distribution that was not seen with the corresponding sidebranch treated with the Sideguard stent. Long term follow up will determine the impact of this phenomenon on ostial sidebranch stenosis.”
The study measured the effects of balloon expandable and self-expanding Sideguard nitinol stents on the vessel wall. The IVUS data showed that the trumpet-shaped self-expanding Sideguard stent contributed to vessel remodeling and also reduced plaque redistribution and carina shift when the Sideguard was placed in the coronary sidebranch vessel as a first line treatment. Dr. Gary Mintz stated that the, "Expansion of a balloon expandable stent in the main vessel of a bifurcation lesion was associated with axial plaque distribution that was not seen with the corresponding sidebranch treated with the Sideguard stent. Long term follow up will determine the impact of this phenomenon on ostial sidebranch stenosis." The full study results will be presented in May 2011 at the EuroPCR meeting in Paris.
Michael Gilmore, Vice President of R&D, Clinical, and Regulatory at Cappella Medical, said, "The Cappella Sideguard coronary sidebranch technology was developed to protect the ostium of the sidebranch which, in turn, will preserve the sidebranch coronary artery. The clinical data that was presented today validates our belief that the Sideguard addresses an unmet need for the protection, and preservation, of the coronary sidebranch artery. We look forward to additional clinical data in the coming months."