Cappella Medical announces positive long term follow-up results for its Sideguard Technology at TCT 2012

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Cappella has announced the multicentre long term follow-up results for its Sideguard coronary side branch stent. Long term follow-up data on the stent was obtained from 399 patients from the United Kingdom, Germany, and Italy. The MACE rate was: 3.7% (30 day follow-up), 7.1% (six months follow-up) and 10.2% (one year follow-up) comparing favourably with existing standard practice.

 

These data represent the largest multicentre clinical experience to date with the Sideguard technology. The stent was developed to protect the ostium of the sidebranch offering a dynamic, effective, and easy-to-use solution in the treatment of bifurcation disease. Results from this 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.

Farzin Fath-Ordoubadi, Cath Lab director at the Heart Centre, Manchester Royal Infirmary, UK 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 multi-centre 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 percutaneous coronary intervention patients have bifurcation disease but there is not one proven dedicated treatment solution to date. 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 were not 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 drug-eluting stent struts in an attempt to provide clear access into the sidebranch. Data are 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 drug-eluting stent treatment options.”
 

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