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www.fdanews.com/articles/69594-akonya-eliminator-plus-enters-u-s-european-markets

AKonya Eliminator Plus Enters U.S., European Markets

March 8, 2005

IDev Technologies has received 510(k) clearance from the FDA to market the AKonya Eliminator Plus Mechanical Thrombectomy Device in the U.S. and has commercially released the CE-Marked device into the European market, the company said.

The AKonya Eliminator Plus is the latest edition to the Eliminator family of products, allowing for 0.018-in. guidewire compatibility, enhanced flexibility and high radial force. The system is a non-motor driven mechanical thrombectomy device intended for the declotting of native arteriovenous fistula and synthetic dialysis grafts.

"Our device's ability to remove adherent clot through wall contact, coupled with the guidewire compatibility which allows for maintenance of position following the crossing of difficult lesions, will result in the AKonya Eliminator Plus quickly becoming the declotting tool of choice," said IDev President and CEO Jeffery Sheldon.