HOUSTON, March 7 /PRNewswire/ -- IDev Technologies, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the AKonya Eliminator Plus(TM) Mechanical Thrombectomy Device in the United States. IDev also announces the commercial release of the CE-Marked AKonya Eliminator Plus(TM) into the European Market.
The AKonya Eliminator Plus(TM) (EL10060061) is the latest edition to the Eliminator(TM) family of products, allowing for .018" guidewire compatibility, enhanced flexibility, and high radial force. The system is a non-motor driven mechanical thrombectomy device intended for the declotting of native arterio venous (AV) fistula and synthetic dialysis grafts. Axial, rotational, and/or pulsitile movements serve as mechanisms of action for thrombus maceration and removal. The continuously adjustable Thrombasket(TM) is highly radiopaque for easy visualization and maintains wall contact throughout the entire procedure providing for removal of adherent clot.
Adherent clot, a precursor to the degradation of dialysis patient access, poses a significant problem for interventional radiologists and vascular surgeons. Dialysis patients would prefer to limit the number of declotting interventions required to maintain their life sustaining access. Opinion leaders believe that removal of adherent clot present within the patient’s synthetic graft or native AV fistula access with a wall contacting device will increase patient satisfaction and clinical outcome. “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(TM) quickly becoming the declotting tool of choice,” stated Jeffery J. Sheldon, IDev Technologies, Inc. President & CEO.
IDev Technologies, Inc. has already launched two products in the U.S. and European markets and anticipates the launch of additional products in early 2005. The AKonya Eliminator(TM) (EL10060060) received FDA market clearance and CE-Mark approval in late 2003 and has been successfully selling worldwide through a network of distributors. “We are delighted to be providing the U.S. and European markets with another safe, cost-effective, and elegant solution for the removal of thrombus in both native and synthetic vessels,” stated Mr. Sheldon.
For more information about IDev Technologies, Inc., please call (281) 333-1998, email us at sales@idevtechnologies.com , or visit us on the web at http://www.idevtechnologies.com/ .
IDev Technologies, Inc.
CONTACT: Becky Cook, Marketing Manager of IDev Technologies, Inc.,+1-281-333-1998, or sales@idevtechnologies.com
Web site: http://www.idevtechnologies.com/
