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QuiremScout™, the first and only product indicated for SIRT work-up, receives CE mark

07/01/2019 - Leuven, Belgium

​Terumo Europe today announced that QuiremScout™ has received CE mark, making it available for clinical centers throughout Europe. QuiremScout™ is designed to advance the SIRT work-up procedure. It does this by improving the accuracy of predicting lung shunting1 and the intrahepatic distribution2, which aims to optimize SIRT patient selection and treatment planning. QuiremScout™ has been developed by Quirem Medical and will be exclusively distributed by Terumo.

"The commercial introduction of QuiremScout is an important next step towards what we believe will be a true paradigm shift in SIRT," said Peter Coenen, President of Interventional Systems Terumo EMEA. "QuiremScout paves the road for increasing confidence in SIRT patient selection and to allow for personalized treatment planning based on each patients individual needs. QuiremScout completes our SIRT portfolio, which is built around QuiremSpheres® and Q-Suite™."

Up until today, Tech-99m-MAA (99mTc-MAA) is used for SIRT work-up procedures around the world in the absence of an alternative.  The limited predictive value of 99mTc-MAA has been recognized by the field3.4  and this is why QuiremScout has been developed.

QuiremScout has the potential to truly improve the accuracy of the SIRT work-up procedure. It leverages the unique features of Holmium-166 PLLA-microspheres," Frank Nijsen, Chief Scientific Officer of Quirem Medical and Associate Professor Interventional Nuclear Medicine at the Radboud University Medical Center in the Netherlands explains "Holmium microspheres emit primary gamma photons and can therefore be imaged in low concentrations using SPECT. Because the scout dose particles are identical in terms of size, weight and shape as those used for QuiremSpheres® therapy, the scout dose gives an improved prediction of the post-therapeutic lung shunt. We expect QuiremScout will also lead to improved prediction of the extrahepatic deposition and intrahepatic absorbed dose distribution."

"QuiremScout has improved our clinical SIRT practice," Prof. Dr. M. Lam, Head of Nuclear Medicine at the University Medical Center Utrecht (UMCU) said, "Based on data from more than 80 patients, we have demonstrated that QuiremScout is safe5 in this population and is a better predictor for lung shunting than 99mTc-MAA1. As a result, we really feel that we have optimized our SIRT patient selection. In addition, we have established that QuiremScout is also a better predictor for the post-treatment intrahepatic distribution when compared to 99mTc-MAA.2 Notably, QuiremScout in combination with 99mTc-colloid enables Dual-Isotope SPECT/CT technology allowing for rapid auto-segmentation of the healthy liver tissue. In our experience QuiremScout microspheres outperforms 99mTc-MAA. Therefore, we have decided to completely switch to QuiremScout for all QuiremSpheres® work-up procedures."

 

About Terumo

Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with over US$5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.

 

About Quirem Medical

Quirem Medical is an emerging medical device company with a mission to develop the next generation microspheres for selective internal radiotherapy (SIRT) of liver malignancies. Quirem Medical BV is a spin-off company of the University Medical Center Utrecht (UMCU) and commercializes, manufactures and distributes a new type of SIRT microspheres based on the isotope holmium, named QuiremSpheres®. QuiremSpheres® microspheres have received CE mark approval in April 2015 and is currently being used by numerous centers world-wide. In addition, Quirem Medical develops and provides related products, such as Q-Suite™, a CE-marked proprietary software package for converting MRI and SPECT imaging into absorbed dose distributions, and QuiremScout™, a product for SIRT work-up.

 

1 M. Elschot et al.  (⁹⁹m)Tc-MAA overestimates the absorbed dose to the lungs in radioembolization: a quantitative evaluation in patients treated with ¹⁶⁶Ho-microspheres".Eur J Nucl Med Mol Imaging. 2014 Oct;41(10):1965-75.

2 1507.4 - The predictive value of the intrahepatic distribution of 99mTc-macroaggregated albumin and holmium-166 scout dose prior to holmium-166 radioembolization. Dassen et al. CIRSE 2018 abstract

3 H.Paul et al. "Correlation of Technetium-99m Macroaggregated Albumin and Yttrium-90 Glass Microsphere Biodistribution in Hepatocellular Carcinoma: A Retrospective Review of Pretreatment Single Photon Emission CT and Posttreatment Positron Emission Tomography/CT, Journal of Vascular and Interventional Radiology , Volume 28 , Issue 5 , 722 - 730.

Wondergem et al. "99mTc-macroaggregated albumin poorly predicts the intrahepatic distribution of 90Y resin microspheres in hepatic radioembolization" J Nucl Med. 2013 Aug;54(8):1294-301.

5 AJAT Braat et al. "Safety analysis of holmium-166 microsphere scout dose imaging during radioembolisation work-up: A cohort study".Eur Radiol. 2018 Mar;28(3):920-928