Cappella Medical Announces Long-Term Results for Its Sideguard Technology

October 22, 2012—Cappella Medical Devices Ltd. (Galway, Ireland) announced that long-term follow-up results for its Sideguard coronary sidebranch stent were presented at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida.

The company stated that multicenter data on the Sideguard stent were obtained from 399 patients from the United Kingdom, Germany, and Italy. The rate of major adverse cardiovascular events was 3.7% at 30 days, 7.1% at 6 months, and 10.2% at 1-year follow-up, which compares favorably with existing standard practice, the company stated.

Farzin Fath-Ordoubadi, MD, of the Heart Center at Manchester Royal Infirmary, commented on the device in the company's press release. He stated, “The Sideguard stent can be used to treat complex bifurcation lesions in a straightforward manner, with excellent clinical outcomes. The long-term follow-up data from this multicenter 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.”

According to Cappella's press release, the Sideguard was developed to protect the ostium of the sidebranch to provide an effective and easy-to-use solution in the treatment of bifurcation disease. Results from this multicenter 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.

Cappella stated that the device's delivery system features split-sheath, balloon-released technology that ensures precise placement on the ostial borderline. The Sideguard self-expanding, nitinol stent is designed to promote continuous wall apposition and positive remodeling; its trumpet-shaped design conforms to varying characteristics of the sidebranch ostium. Currently, the Cappella Sideguard system has CE Mark approval and is distributed throughout Europe, South America, India, and Canada.