FDA Clears Rex Medical's Cleaner15 Rotational Thrombectomy System

January 15, 2013—Rex Medical, LP (Conshohocken, PA) announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Cleaner15 rotational thrombectomy system, which is indicated for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts. Argon Medical Devices, Inc. (Athens, TX) 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.

According to Rex Medical's press release, the Cleaner15 technology provides an ergonomically designed 7-F catheter-based system that is intended to strengthen currently available treatment options. A disposable, battery-operated, handheld 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 interventionist to effectively navigate through tortuous or thrombosed vascular access sites under fluoroscopic visualization.

Rex Medical noted that the Cleaner15 design incorporates a 0.044-inch wire and a 15-mm amplitude sinusoid tip to macerate thrombus in larger diameter graft and fistulae anatomies. This design is coupled with increased system torque, power, and strength of the original Cleaner technology for effective thrombus management.