Sirtex SIR-Spheres and Siros Delivery System Receive EU MDR Certification

September 16, 2024—Sirtex Medical announced that it has received certification under European Union Medical Devices Regulation (EU MDR) 2017/745 for the SIR-Spheres yttrium-90 (Y90) resin microspheres and its delivery systems, including Siros.

Sirtex also advised that the certification paves the way for the European launch of the Siros delivery system.

In the EU, selective internal radiation therapy with SIR-Spheres is indicated for the treatment of unresectable hepatocellular carcinoma and unresectable metastatic liver tumors from primary colorectal cancer in patients refractory to or intolerant of chemotherapy.

The company noted that the EU MDR places greater emphasis on patient safety measures, risk management, postmarket surveillance, and comprehensive data collection for medical devices seeking European market access.

“As an interventional radiologist, I am excited about the future use of the Siros delivery system,” commented Professor Thomas Helmberger, MD, in the company’s press release. Prof. Helmberger, Head of the Department of Radiology, Neuroradiology, and Minimal-Invasive Therapy at München Klinik Bogenhausen in Munich, Germany, continued, “This device has an intuitive design and a precise control that will facilitate the administration of SIR-Spheres Y90 resin microspheres, and I am looking forward to incorporating it into my practice.”

In August 2020, Sirtex Medical US Holdings, Inc. announced the launch in the United States of the Siros system for the delivery of SIR-Spheres Y90 resin microspheres in the targeted treatment of liver cancer.