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The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, to maintain patency and reduce the need of post-operative intervention surgery. The composite stent is intended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steady support of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction by adhesions. The stent can be removed at any time within 28 days by cooling and self-crimping.

The subject device is supplied sterile for single use. The composite removable sinus stent provides sinus wall support following functional endoscopic sinus surgery. A delivery system is provided to insert the implant. The system contains the following components: Stent: The stent is balloon expandable and composed of an outer polyurethane and inner Nitinol alloy bodies. The stent is designed to accommodate the size and variability of the post-surgical ethmoid cavity anatomy. Once expanded the stent is designed to support the walls of ethmoid cavity, in order to prevent adhesions and middle turbinate lateralization into the septum. Stent can be removed within 4 weeks by cooling and self-crimping. Delivery System: The delivery system is designed to insert, position and deploy the stent, following functional endoscopic sinus surgery, guided by endoscopic direct vision. The delivery system consists of a water filled syringe connected to high compliance low pressure balloon via rigid shaft. The balloon is supplemented with color marker.