Innovative Rotational Thrombectomy Technology Receives 510k Clearance

Conshohocken, PA. , November 24, 2003-Rex Medical, L.P., today announced that it has received 510K Clearance to market its Cleaner™ Rotational Thrombectomy System designed for mechanical declotting of occluded synthetic dialysis access grafts.

Cleaner™ technology is an ergonomically designed, percutaneous 5Fr catheter based system (single piece construction) that is compatible with a 6Fr introducer sheath. A disposable, battery operated hand held drive unit is attached to a wire and rotates at a low speed (4000 RPM). The distal, sinuous shaped tip of the wire facilitates atraumatic mechanical declotting of occluded dialysis access grafts. The outer catheter distal tip and sinuous wire segment are both radiopaque for fluoroscopic visualization.

According to the company, Cleaner™ technology provides the physician base with superior trackability and steerability. This quiet and easy to use system has the ability to effectively operate, negotiate and macerate thrombus around the graft apex and opposing sheath. A second generation design, under current FDA review, will incorporate embolectomy balloon technology on the distal catheter tip for rapid removal of wall adherent thrombus. This will ultimately lead to a corresponding decrease in overall catheter exchanges, procedural steps and time.

There are currently over 400,000 procedures performed annually in the U.S. to repair and clear thrombosed hemodialysis access grafts.

Cleaner™ devices will be available for commercial sale in the U.S. in early 2004.

Rex Medical, L.P., based in Conshohocken, PA, is a privately held medical device company specializing in the development, manufacturing and marketing of paradigm shift, minimally invasive medical devices targeted towards the cardiovascular, venous access, endosurgery and oncology markets. Rex Medical is ISO 9001 certified.