Sinusleeve is a single-use, disposable device used for treating chronic sinusitis, according to the Miami-based company. Sinusleeve is an FDA 510(k)-exempt Class 1 device that the company said it will begin marketing immediately to otolaryngologists in Florida. The patented device fits over rigid, flexible and reusable positioning and suction devices by way of a conforming sleeve. It can accommodate instrumentation of varying sizes and curves, allowing access, simultaneous suction and balloon dilation all in one. It accommodates instruments of varying sizes and curves and its long inflation tube provides positioning options by adapting its reach to a variety of instruments. This allows the surgeon to gain access to hard-to-reach blocked sinuses. During a balloon sinuplasty, the Sinusleeve will be dilated within the patient’s nasal cavity, opening up closed or blocked sinuses to provide relief from the associated chronic pain. When the device is removed from the patient the sinus remains open, with an enlarged ostium to allow trapped fluid to drain.
