Sirtex Medical Certifies SIR-Spheres® Y-90 and Launches SIROS™ System in Europe

Sirtex, a prominent manufacturer of interventional treatment solutions, has recently announced a major milestone. The company has received certification under the Medical Device Regulation (EU) 2017/745 for its SIR-Spheres® Y-90 resin microspheres and their associated delivery systems. This certification sets the stage for the European launch of Sirtex's new SIROS™ Delivery System, enhancing available treatment options for liver cancer.

The new EU MDR certification emphasizes more stringent patient safety measures, comprehensive risk management, post-market surveillance, and extensive data collection for medical devices aiming for European market approval. "Patient health and safety are always at the forefront of our work. 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™," said Matt Schmidt, CEO of Sirtex Medical Inc. He added that this achievement reflects their dedication to delivering innovative products responsibly and ethically.

With the certification, interventional radiologists in Europe now have an additional tool to support patients battling metastatic colorectal cancer (mCRC) and unresectable hepatocellular carcinoma (HCC). Schmidt noted that this milestone underscores the outstanding efforts of their team, the rapid growth of their business, and the groundbreaking interventional oncology solutions they have developed.

The new SIROS™ Delivery System is designed to be intuitive, visual, and adaptable, making it easier for physicians to administer SIR-Spheres® to liver cancer patients. Its user-friendly design and controlled administration aim to provide physicians with greater confidence in the Y-90 delivery. Professor Thomas Helmberger, Head of the Department of Radiology, Neuroradiology, and Minimal-Invasive Therapy at München Klinik Bogenhausen in Munich, Germany, expressed his enthusiasm about the new delivery system. He highlighted its intuitive design and precise control, which will facilitate the administration of SIR-Spheres® Y-90 resin microspheres. He looks forward to incorporating this new system into his medical practice.

SIR-Spheres® are medical devices used in selective internal radiation therapy (SIRT) and are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients who are refractory to or intolerant of chemotherapy.

Sirtex, the company behind these innovations, is a global healthcare entity with offices in the U.S., Australia, Europe, and Asia. The company is committed to improving patients' quality of life and longevity through its cutting-edge, minimally invasive cancer and embolization therapies. Sirtex's leading product, SIR-Spheres® Y-90 resin microspheres, provides targeted radiation therapy for liver cancer.