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Improved rotational thrombectomy system receives 510(k) clearance

Rex Medical : 16 January, 2013  (New Product)
Rex Medical receives 510(k) clearance from the US Food and Drug Administration (FDA) for the Cleaner15 Rotational Thrombectomy System which is indicated for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts.

Argon Medical Devices will lead all marketing and distribution efforts for the original Cleaner and Cleaner15 technologies in the USA, European Union, Latin America, Canada and select Asia-Pacific geographies.

Commenting on the recent FDA action, Rex Medical President, Lindsay Carter, said: "We are pleased to receive FDA Clearance for our Cleaner15 technology. This line extension will augment our commercially available Cleaner portfolio and provide an immediate benefit to the significant global patient population undergoing percutaneous thrombectomy treatment."

Traditionally, mechanical thrombectomy devices have been used for rapid removal of thrombus (blood clot) from occluded synthetic dialysis access grafts and native vessel dialysis fistulae. Cleaner15 technology provides an innovative and ergonomically designed 7Fr catheter based system designed to strengthen currently available treatment options. A disposable, battery operated hand held drive unit is attached to a wire that rotates at (4500 RPM). The distal, sinuous shaped tip of the wire facilitates atraumatic mechanical declotting of occluded haemodialysis access sites. The radiopaque outer catheter distal tip and sinuous wire segment allows the end user to effectively navigate through tortuous or thrombosed vascular access sites under fluoroscopic visualization.

Cleaner15 design incorporates a robust .044inch wire and 15mm amplitude sinusoid tip to macerate thrombus in larger diameter graft and fistulae anatomies. This design coupled with increased system torque, power and strength in addition to the original Cleaner technology will provide the physician base with a broad armamentarium for effective thrombus management.

End-Stage Renal Disease (ESRD) affects more than 600,000 persons in the United States and is growing at a rate of three to four percent annually. It is estimated that this number could grow to over 750,000 patients by the year 2020 with over 500,000 of these patients requiring haemodialysis.

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