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

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

January 22, 2024 By Chris Newmarker

This is a Kallisio illustration of Stentra.
[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 improve patient experiences and quality of life.”

Kallisio licensed the technology behind Stentra from the University of Texas MD Anderson Cancer Center, where gastrointestinal radiation oncology professor Dr. Eugene Koay developed it.

The company is working with cancer centers across the U.S. to launch Stentra.

Filed Under: 510(k), Dental, Food & Drug Administration (FDA), Oncology, Regulatory/Compliance Tagged With: Kallisio

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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