Kallisio has received US Food and Drug Administration (FDA) 510(k) clearance for its 3D-printed oral stent solution, Stentra, designed for precise radiation therapy for head and neck cancer patients.
The device aims to protect healthy tissue by immobilising organs at risk during treatment.
Stentra, a patient-tailored oral stent, has been developed to address the challenge of targeting tumours without affecting surrounding healthy tissue.
By utilising patient-specific oral data and advanced 3D printing technology, the stent ensures accurate radiation delivery, particularly in intensity-modulated radiation therapy.
The device’s ability to immobilise critical areas such as the tongue, lips and other organs at risk, will help in significantly reducing the harmful impact of radiation.
One of the advantages of Stentra is its rapid production time as it can be fabricated in under five days.
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To facilitate the deployment of Stentra, Kallisio is partnering with cancer centres throughout the US.
The solution includes intraoral scanning equipment and a cloud-based clinical portal for ordering. It also allows seamless integration into the radiation oncology workflow.
Kallisio co-founder and CEO Rajan Patel said: “Designed to address each patient’s unique treatment and anatomical needs, Stentra delivers an unmatched level of customisation and effectiveness in addressing the critical need to safeguard healthy tissue during radiation therapy.
“FDA clearance is an exciting milestone in our journey to improve patient experiences and quality of life.”
The technology underpinning Stentra originated from the University of Texas MD Anderson Cancer Center. It was developed by MD Anderson gastrointestinal radiation oncology associate professor Eugene Koay.