A rotational thrombectomy system for rapid removal of thrombus (blood clot) from occluded synthetic dialysis access grafts and native vessel dialysis fistulae has received clearance from US Food and Drug Administration (FDA).
Rex Medical’s Cleaner technology is indicated for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts.
Cleaner technology provides a percutaneous 6Fr catheter-based system designed to augment existing treatment options available to the physician base.
A disposable, battery-operated handheld drive unit is attached to a wire and rotates at 4,000RPM and the distal, sinuous shaped tip of the wire facilitates atraumatic mechanical declotting of occluded haemodialysis access sites.
Argon Medical Devices will lead all marketing and distribution efforts for Cleaner in the US, EU and Canada.