Sam Brusco, Associate Editor09.12.22
Advanced imageable embolic therapy firm ABK Biomedical has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Easi-Vue embolic microspheres to treat arteriovenous malformations (AVMs) and hypervascular tumors.
AVMs happens when blood vessels don’t develop correctly and can cause cutaneous discoloration, sensitivity, pain, and vascular bleeding. Vascular embolization is effective to address the symptoms.
Hypervascular tumors can be either benign or malignant and receive blood supply from an abnormally large number of blood vessels. Microspheres embolization can eliminate blood flow to the tumors.
Aravind Arepally, MD, FSIR, and chief medical dfficer of ABK Biomedical told the press, "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 utilization and optimization of Easi-Vue therapy. Additionally, 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). 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."
AVMs happens when blood vessels don’t develop correctly and can cause cutaneous discoloration, sensitivity, pain, and vascular bleeding. Vascular embolization is effective to address the symptoms.
Hypervascular tumors can be either benign or malignant and receive blood supply from an abnormally large number of blood vessels. Microspheres embolization can eliminate blood flow to the tumors.
Aravind Arepally, MD, FSIR, and chief medical dfficer of ABK Biomedical told the press, "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 utilization and optimization of Easi-Vue therapy. Additionally, 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). 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."