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March 22, 2022
Artio Medical’s Solus Gold Embolization Device Receives FDA Clearance
March 22, 2022—Artio Medical, Inc. announced FDA clearance for the company’s Solus Gold, a next-generation embolization device for peripheral vascular occlusion.
According to the company, the Solus Gold embolization device combines a flexible catheter assembly and a nonporous, balloon-like gold implant for easy delivery, precise placement, and immediate vessel occlusion.
Artio Medical noted that the device delivery system’s flexibility and pushability enable navigation of tortuous vasculature with a controlled expansion and simple mechanical detachment. The implant provides 360° vessel apposition for immediate and complete occlusion, and resists migration and recanalization.
In a Good Laboratory Practices preclinical study, the Solus Gold device achieved immediate occlusion in > 90% of cases, including in large and high flow vessels, and demonstrated 0% migration and 0% recanalization in testing out to 3 months, reported the company.
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