Boston Scientific has announced that it has won FDA approval for its radioembolization technology, TheraSphere Y-90 glass microspheres.
Developed to treat those with hepatocellular carcinoma (HCC), the technology now has approval that will allow patients further access to the therapy. Until now, it has been used under a humanitarian device exemption that limited the number of patients who could be treated with the therapy each year.
According to Boston Scientific, TheraSphere provides a type of selective internal radiation therapy (SIRT) that offers low toxicity by using millions of microscopic glass beads that contain Y-90 or radioactive yttrium. These beads are delivered directly to liver tumours via a catheter. The company's announcement also revealed that treatments can be performed as an outpatient procedure so hospitalisation is not required, reducing the pressure on healthcare systems.
"The FDA approval and the recent NICE recommendation will expand access to TheraSphere, which has demonstrated improvement in both survivability and quality of life through 20 years of clinical trials and real-world outcomes in the more than 70,000 patients globally," said Boston Scientific president of interventional oncology, peripheral interventions Peter Pattison.
"We expect to continue to focus our efforts on bringing this treatment to more patients, both by planning a randomised trial to study the combination of TheraSphere and immunotherapy in patients with HCC not eligible for curative treatments, as well as further investigating the therapy for different cancer segments, including prostate and brain."