IDev Technologies Inc has received 510(k) clearance from the U.S. Food and Drug Administration to market the AKonya Eliminator thrombectomy device in the United States. The device is cleared for use in the declotting of synthetic dialysis grafts.

The AKonya Eliminator is a non-motor driven mechanical thrombectomy device that places the degree of mechanical interaction back into the hands of the clinician. Axial and rotational manipulation of the device's Thrombasket, woven mesh structure, serves as the mechanism of action for thrombus maceration. The device's high radial force and vessel wall compliance allow for removal of adherent clot or highly calcified lesions in various dialysis graft sizes.

"Our recent market clearance represents a significant milestone for the company and we are excited about the planned launch of the product throughout North America," said Jeffery J. Sheldon, president & CEO of IDev Technologies, Inc. Sheldon also stated, "we will immediately begin an aggressive sales and marketing campaign for the AKonya Eliminator in the United States to insure that dialysis patients have access to this important technology." Further, "the positive feedback from our European test marketing activities indicates that substantial sales are on the near term horizon."

Clearance to market the AKonya Eliminator follows recent news of IDev's $2.0 million round of financing successfully closed in July and subsequent establishment of its international division in August. The AKonya Eliminator thrombectomy device also received the CE mark designation in Europe in February of this year for the declotting of synthetic dialysis grafts. "We have had a tremendous year with substantive milestones achieved throughout," said Mr. Sheldon. "Our continuing success has stimulated great interest in the financial and strategic partnering communities and I anticipate that we will be announcing other important events shortly."