Kallisio has acquired US Meals and Drug Administration (FDA) 510(ok) clearance for its 3D-printed oral stent resolution, Stentra, designed for exact radiation remedy for head and neck most cancers sufferers.
The gadget goals to guard wholesome tissue by immobilising organs in danger throughout therapy.
Stentra, a patient-tailored oral stent, has been developed to deal with the problem of focusing on tumours with out affecting surrounding wholesome tissue.
By utilising patient-specific oral knowledge and superior 3D printing know-how, the stent ensures correct radiation supply, significantly in intensity-modulated radiation remedy.
The gadget’s skill to immobilise crucial areas such because the tongue, lips and different organs in danger, will assist in considerably decreasing the dangerous impression of radiation.
One of many benefits of Stentra is its fast manufacturing time as it may be fabricated in underneath 5 days.
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To facilitate the deployment of Stentra, Kallisio is partnering with most cancers centres all through the US.
The answer consists of intraoral scanning tools and a cloud-based medical portal for ordering. It additionally permits seamless integration into the radiation oncology workflow.
Kallisio co-founder and CEO Rajan Patel stated: “Designed to deal with every affected person’s distinctive therapy and anatomical wants, Stentra delivers an unmatched degree of customisation and effectiveness in addressing the crucial have to safeguard wholesome tissue throughout radiation remedy.
“FDA clearance is an thrilling milestone in our journey to enhance affected person experiences and high quality of life.”
The know-how underpinning Stentra originated from the College of Texas MD Anderson Most cancers Middle. It was developed by MD Anderson gastrointestinal radiation oncology affiliate professor Eugene Koay.