Artio Medical this week announced it received FDA clearance for its Solus Gold embolization device for peripheral vascular occlusion.
Solus Gold is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The delivery system uses flexibility and push ability to enable physicians to navigate tortuous vasculature.
“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,” Blaise Baxter, VP of neurovascular and peripheral interventions for Artio Medical, said in a news release. “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.”
Prairie Village, Kansas-based Artio Medical’s embolization device uses a controlled expansion and simple mechanical detachment to provide 360º vessel apposition for immediate and complete occlusion. The non-porous, balloon-like gold implant resists migration and recanalization.
“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,” CEO Nicholas Franano said.
“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,” he continued. “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.”