Delivery System

The XTENT^® Custom NX^® delivery system is powered by NX™ technology which enables the treatment of multiple lesions with a single device. The system consists of a catheter with a protective sheath that contains stent segments and balloon and a handle to control delivery of the catheter and deployment of the stent segments. The sheath that covers the stent segments until deployment not only protects the drug coating but also protects the artery walls from being scraped by exposed stent struts as the system is delivered to the targeted lesion. The sheath has a hydrophilic coating and smooth outer surface to provide lubricity, and is designed with the column strength and flexibility needed to advance the catheter to the target lesion. The distal end of the catheter contains a marker for visualization and a proprietary mechanism for separating the interdigitated segments. The handle attached to the catheter controls the deployment and separation of stents.

Stent Delivery

Following the placement of a guidewire, a physician inserts the XTENT Custom NX DES System into the femoral artery and maneuvers the catheter to the site of the target lesion. Opaque markers on the balloon inflation lumen and the sheath allow for visual assessment of stent length and location relative to the target lesion. Features of the handle of the device enable the physician to control the number of stent segments to be deployed and to also separate the exposed stent segments from those remaining protected in the sheath of the catheter. After separation, the physician inflates the balloon to deploy the stent. If needed, the physician can shorten, reposition and reinflate the balloon, in situ, within the stented segments to further expand a portion of the stent against the artery wall. After the stent segments are deployed and the lesion covered, the Custom NX can be reset and, provided that additional segments are available, used to treat additional lesions.