BTG plc, an international specialist healthcare company, with Mirada Medical Ltd, a leading global brand in medical imaging software, announced CE Mark certification for Simplicit90Y dosimetry software, designed to optimise the planning of 90Y selective internal radiation therapy (SIRT) and facilitate personalised treatment for patients with liver cancer. CE Mark certification follows approval for Simplicit90Y in Canada.
BTG, in collaboration with Mirada Medical, have developed Simplicit90Y to be a customised, easy-to-use, dosimetry software developed for rapid 90Y SIRT workflow. Simplicit90Y provides digital processing, review and reporting of medical images with unique options for data display, quality control, image manipulation and quantification analysis. Together, these features allow for more standardised and consistent dosimetry planning and post-treatment validation, and the ability to personalise treatment for each patient.
"Simplicit90Y represents an important advance in providing patients and healthcare providers with added value beyond our products and we are pleased it has received CE Mark certification," commented Zillah Moore, director commercial operations EMEA. "It will ensure 90Y therapies, such as TheraSphere, can be specifically tailored to individual patient needs, facilitating personalised treatments. Simplicit90Y will help us offer interventional oncology teams more power to personalise and optimise 90Y SIRT for their patients. We're delighted Simplicit90Y is now available for physicians to use."
"Dosimetry can be a time intensive and complex process and Simplicit90Y simplifies both dosimetry planning and post-treatment validation," said Etienne Garin, MD, PhD, Chair professor of Nuclear Medicine, Cancer Institute, Centre Eugene Marquis Rennes, France. "Knowing you can use this intuitive software to help deliver a more personalised treatment for each patient, achieving the best dose of 90Y radiation to the tumour while minimising exposure to healthy tissue, gives physicians more confidence."
Matthieu Leclerc-Chalvet, Mirada Medical, managing director commented, "We designed this software to simplify the dosimetry workflow for SIRT and enhance consistency and efficiency. Mirada Medical supports 90Y treatment quality by incorporating advanced image processing tools that facilitate the clinician's use of multi-modal images to plan 90Y SIRT treatment. Leveraging combined expertise from across the industry helped meet both the physician's and patient's needs and Simplicit90Y is a clear demonstration of that success."
Simplicit90Y is a standalone software device intended for use by Nuclear Medicine (NM) or Radiology practitioners for display, processing and reporting of data, including planar scans (Static, Whole Body) and tomographic scans acquired by gamma cameras or PET scanners. Physicians can use the system for viewing and assessing image data for general clinical diagnostic purposes with additional features and optimised workflow for yttrium-90 (90Y) dosimetry.
TheraSphere 90Y glass microspheres are specifically engineered to carry far greater power than any other 90Y liver-directed cancer therapy. TheraSphere works predominantly through radiation, with minimal embolic effect which allows the microspheres to lodge deeper inside the tumor, achieving a high absorbed dose. The result is a powerful, targeted and well-tolerated therapy that may lead to patients becoming eligible for curative therapies.
In the EU, Singapore, South Korea and Canada, TheraSphere is approved for the treatment of hepatic neoplasia. TheraSphere is commercially available in Hong Kong and Malaysia. In the US, TheraSphere is approved under a Humanitarian Device Exemption (HDE) for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. TheraSphere is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment. The effectiveness of TheraSphere for this use in the US has not been demonstrated.