FDA clears Kallisio’s 3D-printed oral insert for radiation therapy

[Stentra illustration courtesy of Kallisio]Kallisio recently announced that the FDA has cleared its 3D-printed Stentra, used to protect head and neck cancer patient’s healthy tissue during radiation therapy.

Stentra is fabricated of bio-compatible nylon materials (nylon ISO 10993-1), using 3D SLS printing technology.

Baltimore-based Kallisio says Stentra directs radiation to the target tumor area while reducing the harmful impact on surrounding tissue. It also immobilizes the tongue, lips, and other at-risk organs.

Stentra fabrication takes place in less than five days.

“Designed to address each patient’s unique treatment and anatomical needs, Stentra delivers an unmatched level of customization and effectiveness in addressing the critical need to safeguard healthy tissue during radiation therapy,” Rajan Patel, Kallisio co-founder and CEO, said in a news release. “FDA clearance is an exciting milestone in our journey to …

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