#USA #liver cancer #Woburn #Sirtex Medical #Y-90 Microspheres

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

Sirtex Medical, a renowned innovator in the field of minimally invasive interventional oncology, has recently announced an essential expansion of its CE marking for the SIR-Spheres® Y-90 resin microspheres, aimed at treating liver cancer patients. This pivotal change enhances the therapeutic access for patients suffering from primary liver cancers and secondary liver metastases across Europe.

Matt Schmidt, CEO of Sirtex Medical, emphasized that this milestone transcends mere regulatory approval; it's about reinstating hope and offering various treatment options for patients confronted with some of the most challenging cancer diagnoses. The broadening of access to SIR-Spheres® is a significant advancement, ensuring that more individuals can benefit from a well-tolerated and established therapy when they need it the most.

The treatment process, known as radioembolization or selective internal radiation therapy (SIRT), delivers Yttrium-90 directly into the tumor via the hepatic artery. This administration allows for a high-dose, targeted radiation therapy that minimizes damage to surrounding healthy tissues. According to Professor Dr. Jens Ricke, the Director of the Department of Radiology at Ludwig-Maximilians University Hospital in Munich, Germany, the Y-90 radioembolization has long been recognized for its clinical efficacy in addressing complex liver tumors. The recently expanded CE marking will ensure that a greater number of patients gain access to this life-extending, quality-of-life-enhancing form of treatment, especially when other therapies fail.

This CE marking extension follows a comprehensive review of clinical data that demonstrated the safety and efficacy of SIR-Spheres® for a range of liver metastases. With the previous FDA approval of SIR-Spheres® Y-90 microspheres for treating inoperable HCC in the United States, this milestone further solidifies the global recognition of SIR-Spheres® as a versatile, differentiated treatment option and underscores Sirtex's commitment to advancing interventional oncology in liver conditions.

For healthcare professionals interested in integrating SIR-Spheres® into their practice, detailed information is available via email at Sirtex. The approved uses of SIR-Spheres® Y-90 microspheres in Europe include:
- Non-resectable hepatocellular carcinoma (HCC)
- Non-resectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients who are refractory to or intolerant of chemotherapy
- Non-resectable intrahepatic cholangiocarcinoma (iCCA)
- Hepatic metastases from neuroendocrine tumors (mNET)
- Other liver metastases

It is important to refer to the product's instructions for a complete list of indications, contraindications, side effects, warnings, and precautions.

About Sirtex
Sirtex Medical is a globally recognized healthcare company dedicated to the development of minimally invasive liver-targeted cancer and embolization therapies. With a presence in the US, Australia, Europe, and Asia, Sirtex offers innovative solutions to healthcare providers and patients worldwide in interventional oncology. For more information, visit www.sirtex.com.