BioSphere's tumour therapy:
This article was originally published in Clinica
US firm Biosphere has received FDA 510(k) approval for its proprietary device for treating hypervascularised tumours and peripheral arteriovenous malformations using embolisation therapy. The device - QuadraSphere Microspheres - is introduced into the blood vessels that supply hypervascularised tumours using an image-guided minimally-invasive technique. US shipments of the product are expected to begin immediately. The technology is already marketed in Europe under the name HepaSphere for treating primary and metastatic liver cancer. However, the US FDA requires that the company run further US clinical trials before it can be promoted specifically for use for this indication. The Rockland, Massachusetts company claims to have pioneered the use of microsphere embolisation technologies for treating symptomatic uterine fibroids.
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