ABK Biomedical announced today that it received FDA 510(k) clearance for its Easi-Vue embolic microspheres for treating tumors.
Halifax, Nova Scotia-based ABK designed its microspheres for treating patients with arteriovenous malformations and hypervascular tumors.
Vascular embolization is an effective therapy for addressing symptoms of these conditions. ABK said in a news release that microsphere embolization reduces or eliminates the blood flow to the tumors.
Chief medical officer Dr. Aravind Arepally said that Easi-Vue microspheres offer a highly calibrated technology. They offer capabilities for visually targeted placement using conventional x-ray and fluoroscopy systems. He added that the technology, with a proprietary controlled-concentration delivery system, could potentially 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 utilization and optimization of Easi-Vue therapy.”
The company is also developing Eye90 microspheres for treating unresectable hepatic cellular carcinoma.
“ABK continues to significantly advance the development program of our Eye90 microspheres radio-embolic technology that’s being investigated for the treatment of patients with unresectable Hepatic Cellular Carcinoma (HCC),” Donofrio said. “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.”