ABK Biomedical’s Easi-Vue Embolic Microspheres Cleared by FDA to Treat Arteriovenous Malformations and Hypervascular Tumors

September 12, 2022—ABK Biomedical, Inc. announced FDA 510(k) clearance of the company’s Easi-Vue embolic microspheres for the treatment of patients with arteriovenous malformations and hypervascular tumors.

Aravind Arepally, MD, who is Chief Medical Officer of ABK Biomedical, commented in the company’s press release, “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.”

Gary Donofrio, Chief Business Officer of ABK Biomedical, added, “We are excited to achieve FDA 510(k) clearance for this new technology that has the potential to advance the field of embolic therapies. 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 utilization and optimization of Easi-Vue therapy.”

Mr. Donofrio continued, “Additionally, ABK continues to significantly advance the development program of our Eye90 microspheres radioembolic technology that’s being investigated for the treatment of patients with unresectable hepatic cellular carcinoma. 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.”

The company’s press release noted that Eye90 microspheres are investigational products and are not approved for use in any regulatory jurisdiction outside of approved clinical trials.