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Kallisio achieves FDA 510(k) clearance for 3D printed Stentra

The stent is designed to protect healthy tissue in Head and Neck Cancer (HNC) patients

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Kallisio, a company focused on developing solutions to manage toxicity in cancer care, has achieved FDA 510(k) clearance for its Stentra product, a personally tailored 3D printed oral stent solution designed to protect healthy tissue in Head and Neck Cancer (HNC) patients. Customized for each patient, the Stentra oral immobilization stent effectively directs radiation to the target tumor area while reducing the harmful impact on surrounding tissue.

By integrating patient oral data with advanced 3D printing, Stentra is meticulously tailored to mitigate target positioning discrepancies associated with radiotherapy methods like IMRT (intensity-modulated radiation therapy). A Stentra device immobilizes the tongue, lips, and other OARs (organs at risk) – keeping them clear of the high-dose radiation target zone.

Kallisio achieves FDA 510(k) clearance for 3D printed Stentra - designed to protect healthy tissue in Head and Neck Cancer (HNC) patients. Key benefits of Stentra include high treatment accuracy, effective toxicity management, and rapid scan-to-stent delivery in less than 5 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,” said Rajan Patel, Co-founder and CEO of Kallisio. “FDA clearance is an exciting milestone in our journey to improve patient experiences and quality of life.”

The foundational technology behind Stentra was licensed by Kallisio from The University of Texas MD Anderson Cancer Center, where it was developed by Eugene Koay, MD, PhD., Associate Professor of Gastrointestinal Radiation Oncology at MD Anderson.

Kallisio is collaborating with cancer centers across the US to launch Stentra. The solution includes top-tier intraoral scanning equipment and a cloud-based clinical portal ordering system with real-time monitoring, best-in-class compliance, and seamless integration into the radiation oncology workflow.

The company has disclosed that Dr. Koay serves in an advisory role with Kallisio. MD Anderson has an institutional conflict of interest with Kallisio, and this relationship will be managed according to an MD Anderson Conflict of Interest Management and Monitoring Plan.

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Edward Wakefield

Edward is a freelance writer and additive manufacturing enthusiast looking to make AM more accessible and understandable.

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