Technology | March 12, 2010

Rotational Thrombectomy System Cleared for Dialysis Grafts

March 12, 2010 – A rotational thrombectomy system has been indicated for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts.

Argon Medical Devices Inc. will lead all marketing and distribution efforts for the Cleaner Rotational Thrombectomy System from Rex Medical L.P. in the United States, European Union and Canada.

Traditionally, mechanical thrombectomy devices have been used for rapid removal of thrombus from occluded synthetic dialysis access grafts and native vessel dialysis fistulae. Cleaner technology provides an innovative and ergonomically designed, percutaneous 6 French catheter based system designed to augment current treatment options available to the physician base.

A disposable, battery-operated, hand-held drive unit is attached to a wire and rotates at 4,000 RPM. The distal, sinuous shaped tip of the wire facilitates atraumatic mechanical declotting of occluded hemodialysis access sites. The radiopaque outer catheter distal tip and sinuous wire segment allows the end user to effectively navigate through tortuous or thrombosed vascular access sites under fluoroscopic visualization.

End-stage renal disease (ESRD) affects more than one in 1,000 persons in the United States and is growing at a rate of 5 to 7 percent annually.

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