The Food and Drug Administration (FDA) has given 510(k) clearance to Rex Medical for its Cleaner15 Rotational Thrombectomy System, indicated for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts.
The company announced that Argon Medical Devices 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 from occluded synthetic dialysis access grafts and native vessel dialysis fistulae. A company release states that the Cleaner15 technology provides an innovative and ergonomically designed 7Fr catheter based system designed to strengthen currently available treatment options. The device features a disposable, battery operated hand held drive unit which is attached to a wire that rotates at (4500 RPM). The distal, sinuous shaped tip of the wire facilitates atraumatic mechanical declotting of occluded haemodialysis 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 visualisation.
Cleaner15 design incorporates a robust .044” wire and 15mm 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.