FDA clears thrombectomy system

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Rex Medical has received 510(k) clearance from the FDA for its Cleaner15 rotational thrombectomy system, with an indication for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts.

Traditionally, mechanical thrombectomy devices have been used for rapid removal of thrombus from occluded synthetic dialysis access grafts and native vessel dialysis fistulae. Cleaner15 technology provides a 7Fr catheter-based system.

A disposable, battery operated hand held drive unit is attached to a rotating wire. 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 end user to navigate through tortuous or thrombosed vascular access sites under fluoroscopic visualization, according to Conshohocken, Pa.-based Rex Medical.