#USA #liver cancer #Woburn, MA #Sirtex Medical #SIR-Spheres

Sirtex Medical's Expanded CE Mark for SIR-Spheres® Y-90

Sirtex Medical, a leader in minimally invasive oncology solutions, has recently announced the expanded CE mark for its SIR-Spheres® Y-90 resin microspheres intended for liver cancer treatment. This significant approval now includes eligibility for both primary and secondary liver metastases, allowing more patients access to a targeted therapy that can influence their treatment journey positively.

A Major Milestone in Oncology

According to Matt Schmidt, CEO of Sirtex Medical, this milestone extends beyond mere regulatory approval. It represents a renewed hope for patients facing some of the toughest cancer diagnoses. With the expanded access to SIR-Spheres®, more patients will benefit from this well-tolerated therapy precisely when they need it the most. The therapy operates through a technique called radioembolization, or Selective Internal Radiation Therapy (SIRT), whereby Yttrium-90 is directly delivered to tumors via the hepatic artery, aiming to minimize damage to surrounding healthy tissue while administering a concentrated dose of radiation.

Clinical Value of Yttrium-90

Renowned medical expert Jens Ricke from the University Hospital Ludwig-Maximilians in Munich, Germany, emphasized the clinical value of Y-90 radioembolization in treating complex liver tumors. The extended CE mark signifies a crucial enhancement in patient care, enabling more individuals to benefit from a therapy that can potentially prolong life and enhance quality of life when other treatments may no longer be effective.

Rigorous Data Review

The CE mark expansion follows an extensive review of clinical data demonstrating the safety and effectiveness of SIR-Spheres® across various liver metastases. This recent achievement complements the FDA's approval of SIR-Spheres® Y-90 for treating unresectable hepato-cellular carcinoma (HCC) in the United States. This momentum underscores the growing global recognition of SIR-Spheres® as a versatile and differentiated therapy.

Global Commitment to Innovative Oncology

Sirtex Medical's commitment to advancing interventional oncology for liver cancer is evident not just in recent approvals, but in its global presence. With offices strategically located in the US, Australia, Europe, and Asia, the company aims to deliver minimally invasive interventional oncology solutions to physicians and patients worldwide.

What SIR-Spheres® Can Treat

In Europe, the SIR-Spheres® Y-90 resin microspheres are indicated for several conditions:

• - Unresectable hepatocellular carcinoma (HCC)
• - Unresectable metastatic liver tumors from primary colorectal cancer (CRC) in patients who are refractory or intolerant to chemotherapy
• - Unresectable intrahepatic cholangiocarcinoma (ICC)
• - Metastatic liver tumors from neuroendocrine tumors (NETs)
• - Other liver metastases

Precaution: Always refer to the product's instructions for a comprehensive list of indications, contraindications, side effects, warnings, and precautions.

Looking Ahead

As Sirtex Medical continues to evolve and adapt its therapies to the needs of patients, this expanded CE mark for SIR-Spheres® Y-90 represents not just a regulatory achievement but a crucial advancement in cancer treatment. The goal remains to provide hope and improved options for individuals facing liver cancer, ensuring they receive the care they need when they need it most. For more information on integrating SIR-Spheres® into practice, readers can contact Sirtex at [email protected].

To find out more about Sirtex Medical and its innovative solutions, visit their official website at www.sirtex.com.