ABK Biomedical has announced US Food and Drug Administration (FDA) 510(k) clearance of Easi-Vue embolic microspheres for the treatment of patients suffering from arteriovenous malformations and hypervascular tumours.
Aravind Arepally, chief medical officer of ABK Biomedical said: “The evolution of embolic therapies to treat these complex disease states has been notable in recent years. Now, with Easi-Vue embolic microspheres, interventional radiologists have a highly calibrated, see-and-do technology capable of visually targeted placement using conventional X-ray and fluoroscopy systems. This microspheres technology and proprietary controlled-concentration delivery system have the potential to improve patient outcomes.”
“We are excited to achieve FDA 510(k) clearance for this new technology that has the potential to advance the field of embolic therapies”, said Gary Donofrio, chief business officer of ABK Biomedical. “This represents a major milestone for ABK as our team continues to execute our product development objectives. We will partner with key physicians to understand the range of clinical utilisation and optimisation of Easi-Vue therapy. Additionally, ABK continues to significantly advance the development programme of our Eye90 microspheres radioembolic technology that is being investigated for the treatment of patients with unresectable hepatic cellular carcinoma (HCC). Easi-Vue embolic microspheres share core technologies and design characteristics with Eye90 microspheres. Both devices continue to add to our knowledge base regarding the clinical experience of the first glass radiopaque embolic microspheres therapy.”