Boston Scientific has announced that it has received US Food and Drug Administration (FDA) clearance for its any day dosing feature on its TheraSphere 360 yttrium-90 (Y-90) management platform.
In a recent press release the company shares that care teams who treat patients with liver cancer using Boston Scientific’s potent radiation therapy, TheraSphere Y-90, will now have more options to administer it any day of the week.
“The FDA clearance of any day dosing powered by TheraSphere 360 reflects our continued investment in advancing digital solutions that support Y-90 care teams,” said Peter Pattison, president of Interventional Oncology and Embolization at Boston Scientific. “By integrating Any day dosing capabilities into the TheraSphere 360 platform, we are expanding treatment scheduling options while maintaining a streamlined, connected experience for our customers.”
TheraSphere any day dosing is made possible by an additional manufacturing cycle for its Y-90 glass microspheres. TheraSphere dosing is determined in part by the number of days after the microspheres are calibrated with radiation. Because radioactive Y-90 decays at a predictable rate, physicians can precisely calculate and deliver the intended radiation to the tumour with precision. Historically, the microspheres were only calibrated on one day per week, which limited vial availability on specific days.
The additional manufacturing cycle introduces a second calibration date, expanding scheduling flexibility and enabling physicians to treat on more days of the week while maintaining their intended radiation activity per microsphere and prescribed sphere count.
TheraSphere is the most studied, evidence-based Y-90 therapy, which is a targeted treatment option, including use as a bridging strategy for appropriate patients with hepatocellular carcinoma (HCC) awaiting liver transplantation in the USA.
