FDA OKs Artio Medical’s Solus Gold Embolization Device

Peripheral vascular, neurovascular, and cardiology device company Artio Medical earned U.S. Food and Drug Administration (FDA) clearance for its Solus Gold embolization device for peripheral vascular occlusion.
 
Solus Gold obstructs or reduces blood flow rate in peripheral vasculature. The delivery system’s balance of pushability and flexibility helps physicians navigate tortuous vasculature.
 
After controlled expansion and simple mechanical detachment, a non-porous, balloon-like implant allows 360-degree vessel apposition for instant and complete occlusion. It resists migration and recanalization for a “one and done” peripheral vascular tool, according to Artio.
 
“Current occlusion devices can be difficult to position in challenging anatomy, often require multiple implants, and usually take time to completely occlude the target vessel. This can be a problem when physicians need to control or prevent bleeding and reduce the risk of further complications,” Dr. Blaise Baxter, VP of Neurovascular and Peripheral Vascular Interventions for Artio Medical told the press. “The Solus Gold device aims to overcome these limitations with a single implant designed for precision placement and immediate occlusion, even in high-flow vessels and short landing zones.”
 
“We would like to thank the FDA for providing helpful input to the Artio team through the Q-Submission process, and for the careful and thoughtful review of our 510(k) application. I would also like to thank the talented and dedicated Solus Gold product development team at Artio, our many partners in the industry, and our supportive investors for helping Artio reach this important milestone,” added F. Nicholas Franano, MD, president and CEO of Artio. “When I first learned to embolize vessels using small metal coils more than 20 years ago, I thought surely someone will come up with a better device for doing that. As we prepare for the market release of the Solus Gold device later this year, I am excited to have the opportunity to provide physicians and patients with an improved peripheral vascular embolization experience.”