FDA Clears Kallisio's Patient-Specific Oral Stent for Head and Neck Cancer Treatment

Friday, January 19, 2024

Kallisio has obtained FDA 510(k) clearance for its Stentra, a personalized 3D printed oral stent tailored for individuals undergoing treatment for Head and Neck Cancer (HNC). Developed with a focus on managing toxicity in cancer care, Stentra is designed to deliver targeted radiation to the tumor area while safeguarding surrounding healthy tissue.

By utilizing advanced 3D printing technology and incorporating patient-specific oral data, the stent addresses potential discrepancies in positioning associated with radiotherapy methods, including IMRT (intensity-modulated radiation therapy). Stentra effectively immobilizes critical areas, such as the tongue and lips, preventing exposure to high-dose radiation in the target zone.

The key advantages of Stentra include precise treatment accuracy, efficient toxicity management, and a quick turnaround time for fabrication, completed in less than 5 days. Kallisio is actively collaborating with cancer centers across the United States to introduce Stentra. The comprehensive solution includes state-of-the-art intraoral scanning equipment, a cloud-based clinical portal ordering system, real-time monitoring, superior compliance features, and seamless integration into the radiation oncology workflow.





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