The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to Kallisio’s 3D-printed oral stent Stentra that is designed to protect healthy tissue during head and neck cancer (HNC) radiation therapy.
The device immobilizes the tongue, lips, and other organs at risk, keeping them clear of the radiation target zone and reducing harm to healthy tissue, Kallisio said in a press release. Using patient data and 3D printing, the stent is customized to mitigate target positioning discrepancies associated with radiotherapy methods, like intensity-modulated radiation therapy, the company added. Kallisio is collaborating with cancer centers in the U.S. to launch Stentra.
