Sirtex’s Precision Radiation Spheres Gain EU Certification
Sirtex Medical, a company known for developing treatments for liver cancer, has received EU certification for its SIR-Spheres Y-90 resin microspheres and launched its new SIROS Delivery System in Europe. This expansion brings new treatment options for patients with specific types of liver cancer and helps doctors deliver cancer-fighting radiation more precisely.
Understanding SIR-Spheres Y-90 Microspheres
SIR-Spheres Y-90 microspheres are tiny radioactive beads used in a procedure called Selective Internal Radiation Therapy (SIRT). These microspheres are tiny resin beads, approximately 32 microns in diameter, about a third the width of a human hair, and have a density similar to blood cells, allowing them to move easily through the bloodstream. They contain the radioactive element yttrium-90, which delivers high doses of radiation over a short distance, directly targeting tumor tissues while sparing much of the surrounding healthy liver tissue. This makes the treatment less harmful to the rest of the body compared to traditional radiation therapy.
The microspheres are specifically designed to treat liver cancers that cannot be removed by surgery. They are used in patients with hepatocellular carcinoma (HCC), a common type of liver cancer, and metastatic liver tumors from colorectal cancer when patients do not respond to or cannot tolerate chemotherapy.
Why the EU Certification Matters
Receiving certification under the EU Medical Device Regulation (MDR) is a big deal for Sirtex because it allows their products to be used in Europe. The EU MDR is a strict set of rules that focus on making sure medical devices are safe and effective. It requires companies to provide detailed data about how their devices work, how they are tested, and how patients are monitored after treatment.
Matt Schmidt, CEO of Sirtex Medical, highlighted the importance of this achievement:
“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. This achievement underscores our commitment to delivering innovative products responsibly and ethically. With the expansion of SIROS outside of the U.S., interventional radiologists in Europe now have an additional option to support patients battling metastatic colorectal cancer and unresectable hepatocellular carcinoma. This milestone reflects the outstanding efforts of our team, the rapid growth of our business, and the groundbreaking interventional oncology solutions we have developed.”
What the SIROS Delivery System Brings
The SIROS Delivery System is a new tool that helps doctors deliver SIR-Spheres more easily and accurately. It provides a visual guide and control to ensure the beads are placed exactly where they need to be in the liver. This system makes the procedure more straightforward for doctors and could lead to better outcomes for patients.
Professor Thomas Helmberger, a leading radiologist from Munich, praised the new system:
“As an interventional radiologist, I am excited about the future use of the SIROS Delivery System. This device has an intuitive design and precise control that will facilitate the administration of SIR-Spheres Y-90 resin microspheres, and I am looking forward to incorporating it into my practice.”
Why This Technology is Important
The SIR-Spheres Y-90 microspheres and SIROS Delivery System represent a significant advancement in cancer treatment because they allow for targeted radiation therapy. Traditional radiation affects both cancerous and healthy tissues, leading to more side effects. By delivering radiation directly to the tumor, SIR-Spheres minimize damage to healthy cells, making the treatment safer and more effective.
For many patients with liver cancer that cannot be surgically removed, these therapies offer a vital alternative. They provide hope for better outcomes when other treatments, like chemotherapy, fail or cause intolerable side effects.
Company Background
Sirtex Medical operates globally, including in the U.S., Australia, Europe, and Asia, focusing on innovative, minimally invasive cancer treatments. The company’s main product, SIR-Spheres Y-90 microspheres, offers a targeted approach to treating liver cancer, aiming to improve patients' quality of life and extend survival.
With its latest expansion into Europe, Sirtex continues to provide advanced solutions that meet the evolving needs of cancer patients and healthcare providers, aligning with the global trend towards more personalized and precise medical treatments.
Topics: Tools & Methods
