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March 10, 2010
Rex Medical's Cleaner System Receives FDA Clearance
March 11, 2010—Rex Medical (Conshohocken, PA) and Argon Medical Devices, Inc. (Athens, TX) announced that Rex's Cleaner rotational thrombectomy system has received 510(k) clearance from the US Food and Drug Administration. Argon will lead all marketing and distribution efforts for the Cleaner system in the United States, European Union, and Canada, the companies stated.
According to the companies, the Cleaner device is indicated for mechanical declotting of occluded native vessel dialysis fistulas and synthetic dialysis access grafts. The Cleaner technology is an ergonomically designed, percutaneous, 6-F catheter-based system that augments the current options available for end-stage renal disease treatment. The device features a disposable, batteryoperated, handheld drive unit that 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 allow the interventionist to effectively navigate through tortuous or thrombosed vascular access sites under fluoroscopic visualization.
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