FDA clears oral stent solution for radiotherapy in head and neck cancer
Source: www.cancernetwork.com Author: Russ Conroy The FDA has granted clearance to Stentra, an oral stent solution, for use in the treatment of patients with head and neck cancer, according to a press release from Kallisio.1 The solution combines patient oral data with advanced 3D printing to redirect radiation to the target tumor area and limit toxicity to surrounding tissue. Stentra was designed for use in combination with radiotherapy strategies including intensity-modulated radiation therapy (IMRT). The tool is believed to keep the patient’s tongue, lips, and other organs safe from the high-dose radiation target zone by immobilizing them. According to its developers, Stentra makes use of a “patient-customized solution for precise and targeted radiation therapy,” and manages toxicity effectively by protecting surrounding healthy tissue from intense radiation doses. Additionally, its mechanism allows patient-tailored oral stents to be formed 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,” Rajan Patel, co-founder and chief executive officer at Kallisio, said in the press release.1 “FDA clearance is an exciting milestone in our journey to improve patient experiences and quality of life.” Eugene Koay, MD, PhD, an associate professor of Gastrointestinal Radiation Oncology at The University of Texas, MD Anderson Cancer Center, developed Stentra’s foundational technology. Investigators of a prospective observational study published in Clinical and Translational Radiation Oncology reported that administering oral stents to survivors of oropharyngeal [...]