EU MDR authorization enables Woburn, Massachusetts-based Sirtex to kick off a European launch for its Siros delivery system.
Siros offers an intuitive, visual and adaptable solution for physicians to administer SIR-Spheres to liver cancer patients. It features an easy-to-use design with controlled administration to instill confidence in the delivery of Y-90 microspheres.
Sirtex Medical’s SIR-Spheres offer use in selective internal radiation therapy (SIRT). They are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients refractory to or intolerant of chemotherapy.
“Patient health and safety are always at the forefront of our work,” said Matt Schmidt, Sirtex Medical CEO. “That is why we are particularly proud to receive EU MDR certification for SIR-Spheres Y-90 resin microspheres and its delivery systems, including Siros. This achievement underscores our commitment to delivering innovative products responsibly and ethically. With the expansion of Siros outside of the U.S., interventional radiologists in Europe now have an additional option to support patients battling metastatic colorectal cancer (mCRC) and unresectable hepatocellular carcinoma (HCC).
“This milestone reflects the outstanding efforts of our team, the rapid growth of our business, and the groundbreaking interventional oncology solutions we have developed.”
