Rex Medical receives FDA Clearance for Cleaner Rotational Thrombectomy System

Rex Medical, L.P., today announced that it has received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) for the Cleaner™ Rotational Thrombectomy System. Cleaner™ technology is 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 Cleaner™ in the United States, European Union and Canada.

“we are pleased to receive FDA Clearance for our Cleaner™ technology in the declotting of native vessel dialysis fistulae in addition to synthetic dialysis access grafts. This will provide an immediate benefit to the significant global patient population undergoing treatment for ESRD.”

Traditionally, mechanical thrombectomy devices have been used for rapid removal of thrombus (blood clot) from occluded synthetic dialysis access grafts and native vessel dialysis fistulae. Cleaner™ technology provides an innovative and ergonomically designed, percutaneous 6Fr 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 (4000 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 1 in 1,000 persons in the United States and is growing at a rate of 5%-7% annually. It is estimated that this number could grow to over 750,000 patients by the year 2020 with over 500,000 of these patients requiring hemodialysis.

Commenting on the recent FDA action, Rex Medical President, Lindsay L. Carter, “we are pleased to receive FDA Clearance for our Cleaner™ technology in the declotting of native vessel dialysis fistulae in addition to synthetic dialysis access grafts. This will provide an immediate benefit to the significant global patient population undergoing treatment for ESRD.”