Rex's thrombectomy system gets US OK

The Cleaner rotational thrombectomy system developed by Rex Medical (Conshohocken, Pennsylvania) has received 510(k) clearance from the US FDA. The technology is designed for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts. This is necessary in patients with end-stage renal disease (ESRD). The Cleaner technology is comprised of a disposable, battery operated hand held drive unit, which is attached to a wire and rotates at 4,000 RPM. Its radiopaque outer catheter allows the end user to navigate tortuous or thrombosed vascular access sites under fluoroscopy. Argon Medical Devices will lead all marketing and distribution efforts for Cleaner in the EU, the US and Canada. ESRD affects more than 1 in 1,000 persons in the US and is growing at a rate of 5-7% annually. There could be over 750,000 ESRD patients by 2020, more than 500,000 of whom could require haemodialysis.