Cappella Medical Devices

Cappella, Inc. – a medical device company specialising in cardiovascular innovations – has developed the Sideguard® Coronary Sidebranch Stent & Delivery System, offering interventional cardiologists a novel solution for the treatment of coronary bifurcation disease.

Sideguard® – Cappella’s initial product – consists of a uniquely designed self-expanding nitinol coronary stent that makes use of a novel, balloon-catheter, split-sheath delivery system. Both the stent and the delivery system were developed by Cappella Medical Devices Ltd., the R&D and manufacturing subsidiary of Cappella, Inc.

CE-marked in April 2009, Cappella’s Sideguard® offers a new, simple and effective option for treating bifurcation disease, with a focus on treating the sidebranch of the diseased coronary artery first, rather than the main vessel. Moreover, the Sideguard® system allows the preferred stent of choice for the main vessel.

The Sideguard® stent is used in combination with a novel, low-profile balloon-catheter delivery system, which enables straightforward, rapid-exchange delivery and precise stent placement at the sidebranch ostium. During positioning, a sheath encloses the stent; however, once the stent is in place, the delivery system balloon is inflated, and in doing so, the sheath is split and the stent released. The delivery system is then withdrawn, leaving the stent in place. This proprietary split-sheath technology prevents the stent jumping at delivery and ensures accurate deployment of the device.

Bifurcation procedures are complicated, not least owing to the complex and variable anatomy of the coronary ostia. The Sideguard® stent itself is uniquely designed to conform to the anatomy of the sidebranch ostium, and while the elastic property of nitinol enables the stent to self expand so as to adapt to the various ostial morphologies, the mechanical property of nitinol sustains continuous wall apposition and scaffolding. The stent is thus able to dynamically appose the full lumen of the sidebranch, including the ostium. This dynamic apposition results in continuous contact between the stent and the vessel wall, as well as arterial expansion (positive remodelling) over time.

The Sideguard® Coronary Sidebranch Stent & Delivery System offers interventional cardiologists a dynamic new option for treating bifurcation disease. This unique product demonstrates that good product design is able to provide benefits that can be seen in the clinic.