Rex Medical Cleaner15 Rotational Thrombectomy System Receives 510(k) Clearance


January 16, 2013

January 16, 2013 — Rex Medical L.P. announced that it has received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) for the Cleaner15 Rotational Thrombectomy System. Cleaner15 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 the original Cleaner and Cleaner15 technologies in the United States, European Union, Latin America, Canada and select Asia-Pacific geographies.

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. Cleaner15 technology provides an innovative and ergonomically designed 7 French catheter-based system designed to strengthen currently available treatment options. A disposable, battery operated hand-held drive unit is attached to a wire that rotates at 4,500 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.

Cleaner15 design incorporates a robust 0.044 inch wire and 15 mm amplitude sinusoid tip to macerate thrombus in larger diameter graft and fistulae anatomies. This design coupled with increased system torque, power and strength in addition to the original Cleaner technology will provide the physician base with a broad armamentarium for effective thrombus management.

End-Stage Renal Disease (ESRD) affects more than 600,000 persons in the United States and is growing at a rate of 3-4 percent annually. It is estimated that this number could grow to more than 750,000 patients by the year 2020, with more than 500,000 of these patients requiring hemodialysis.

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