Rex Medical L.P. has received 510(k) clearance from the Food and Drug Administration (FDA) for the Cleaner™ rotational thrombectomy system.
Rex Medical is a medical device manufacturer based out of Conshohocken, Pennsylvania. According to the company’s own press release, the Cleaner™ is a wire-based mechanical thrombectomy system that facilities the atraumatic declotting of occluded native and synthetic dialysis sites. The device includes a disposable, hand-held control unit that can rotate the wire at speeds up to 4000 RPM, a 6Ff based catheter system that is compatible with standard 6Fr introducer sheaths, and a radiopaque distal tip and sinuous wire segment for fluoroscopic visualization. The Cleaner™ is designed to augment current treatment options available to physicians.
End stage renal disease (ESRD) affects more than 300,000 people each year in the U.S. alone. The number of affected individuals is expected to reach 750,000 by 2020. Of these 750,000 potential patients, 500,000 of them are anticipated to require hemodialysis.
Texas based Argon Medical Devices Inc. will be responsible for all marketing and distribution of the Cleaner™ device in the United States, Canada and Europe.
More information on the Cleaner™ product can be found at the following link: