Therapy Areas: Devices
CIVCO Radiotherapy and POLL Medical awarded marketing clearance for GrayDuck Stents
12 April 2019 -

Radiotherapy solutions company CIVCO Radiotherapy and POLL Medical on Thursday jointly announced the receipt of US Food and Drug Administration (FDA) 510(k) clearance to market GrayDuck Stents.

The new product provides custom oral positioning with repeatable tongue deviation during radiotherapy.

GrayDuck Stents are designed to improve patient treatment and outcomes by sparing the tongue, taste buds and salivary glands from unnecessary dose. The stent can position the tongue in one of several positions: laterally (left or right), depressing (downward) or a combination thereof.

According to the company's director John Steffen, the ability to offer a custom device that can be formed in less than 15 minutes is very meaningful for the patient and clinical workflow, while still providing high quality positioning necessary for treatment.

GrayDuck stents were issued the US Patent 9,504,537 with additional patents pending worldwide. The stents are available in Europe with CE Mark and now in the US with FDA 510(k) clearance.

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