Sam Brusco, Associate Editor01.18.24
Kallisio has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Stentra, an individually tailored, 3D printed oral stent to protect healthy tissue in head and neck cancer (HNC) patients.
The Stentra oral immobilization stent directs radiation to the target tumor area and reduces harmful impact to surrounding tissue. It integrates the patient’s oral data with 3D printing to help mitigate target positioning discrepancies associated with IMRT (intensity-modulated radiation therapy).
The Stenta device immobilizes the tongue, lips, and other organs at risk to keep them clear of the high-dose radiation zone. The patient-tailored stents can be fabricated in under five days, according to the company.
The solution also features intraoral scanning equipment and a cloud-based portal oerdering system with real-time monitoring.
“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, Kallisio co-founder and CEO. “FDA clearance is an exciting milestone in our journey to improve patient experiences and quality of life.”
Stentra’s foundational technology was licensed by Kallisio from The University of Texas MD Anderson Cancer Center, where it was developed by Eugene Koay, MD, Ph.D., Associate Professor of Gastrointestinal Radiation Oncology at MD Anderson.
The company said it’s working with cancer centers across the U.S. to launch Stentra.
The Stentra oral immobilization stent directs radiation to the target tumor area and reduces harmful impact to surrounding tissue. It integrates the patient’s oral data with 3D printing to help mitigate target positioning discrepancies associated with IMRT (intensity-modulated radiation therapy).
The Stenta device immobilizes the tongue, lips, and other organs at risk to keep them clear of the high-dose radiation zone. The patient-tailored stents can be fabricated in under five days, according to the company.
The solution also features intraoral scanning equipment and a cloud-based portal oerdering system with real-time monitoring.
“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, Kallisio co-founder and CEO. “FDA clearance is an exciting milestone in our journey to improve patient experiences and quality of life.”
Stentra’s foundational technology was licensed by Kallisio from The University of Texas MD Anderson Cancer Center, where it was developed by Eugene Koay, MD, Ph.D., Associate Professor of Gastrointestinal Radiation Oncology at MD Anderson.
The company said it’s working with cancer centers across the U.S. to launch Stentra.