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Sirtex Expands CE Mark Approval for SIR-Spheres® Y-90

Sirtex Medical, a prominent player in the field of minimally invasive interventional oncology solutions, has recently received an expanded CE mark approval for its SIR-Spheres® Y-90 resin microspheres. This pivotal approval extends eligibility for treatment not only to primary liver cancer but also to metastatic liver cancers. This significant development enables greater access to a well-established targeted therapy for patients battling liver cancer across Europe and other regions where CE marking is recognized.

The expansion in indication reflects a crucial step beyond regulatory approval; it embodies the hope and options provided to patients facing some of the most challenging cancer diagnoses, according to Matt Schmidt, CEO of Sirtex Medical. “By broadening access to SIR-Spheres®, we are ensuring that more individuals can benefit from a well-tolerated treatment when they need it the most,” he stated.

Yttrium-90 radioembolization, commonly referred to as selective internal radiation therapy (SIRT), involves delivering radiation directly to tumors through the hepatic artery. This allows for a high-dose targeted irradiation that minimizes damage to surrounding healthy tissues, making it a preferred choice among oncologists.

Professor Jens Ricke, the director of the radiology clinic at Ludwig Maximilians University Hospital in Munich, Germany, highlighted the long-established clinical benefits of Y-90 radioembolization in managing complex liver tumors. With this expanded CE mark approval, it is anticipated that more patients will gain access to a therapy capable of extending life, improving quality of life, and offering hope when other treatments may have failed.

The CE mark expansion comes on the back of a thorough evaluation of clinical data, demonstrating the safety and efficacy of SIR-Spheres® in various liver metastases. Following the recent FDA approval for SIR-Spheres® Y-90 for the treatment of unresectable hepatocellular carcinoma in the United States, this development underscores the growing global recognition of SIR-Spheres® as a versatile and differentiated therapy in the field of oncology.

Sirtex Medical is committed to advancing liver-focused interventional oncology by providing innovative solutions to healthcare professionals and patients worldwide. The company has offices in the United States, Australia, Europe, and Asia, and is dedicated to the mission of transforming the clinical landscape through its pioneering embolization therapies. For healthcare practitioners looking to integrate SIR-Spheres® into their practices, more information can be obtained directly from Sirtex.

In Europe, indications for SIR-Spheres® include treatment for:

• - Unresectable hepatocellular carcinoma (HCC)
• - Unresectable metastatic liver tumors from primary colorectal cancer in chemotherapy-refractory or intolerant patients
• - Unresectable intrahepatic cholangiocarcinoma
• - Metastatic liver tumors from neuroendocrine tumors (mNET)
• - Other various liver metastases

For comprehensive details regarding indications, contraindications, side effects, warnings, and precautions, healthcare professionals should refer to the official product documentation from Sirtex. For more information about the advancements in SIR-Spheres® and its clinical applications, visit Sirtex's website.