New Multi-pronged Injection Needle Receives CE Mark Approval/ 510k Exempt Status (U.S.)
Conshohocken, PA., September 30, 2003-Rex Medical, L.P., today announced the 510K Exempt Status (U.S.) and CE Mark Approval to market the Quadra-Fuse™ Multi-Pronged Injection Needle designed for the infusion of fluids (chemicals, hypertonic saline, etc.) into soft tissue (liver, other organs, etc.).
Quadra-Fuse™ technology is an 18 Gauge stainless steel, multi-pronged injection needle design (27 Gauge needle array) with corresponding array diameters of 1cm, 2cm, 3cm, 4cm, and 5cm. Quadra-Fuse™ is available in 10cm, 15cm, and 20cm (co-axial technique) lengths. This technology combined with an echogenic tip is compatible with both CT and US imaging modalities. MR compatible needle designs are currently under development in addition to Quadra-Fuse ST device technology that will target smaller 1 and 2cm tissue zones.
Quadra-Fuse™ needle technology offers controlled, volumetric and spherical dispersion of fluids into tissue that single source needle designs are unable to provide. Accurate and uniform distribution of multiple fluid agents will ultimately lead to a decrease in overall injection and procedure time. W. Scott Helton, M.D., FACS, Professor and Chief, Division of General Surgery, University of Illinois at Chicago reported, “Quadra-Fuse needle technology provides accurate and uniform distribution of chemical agent into soft tissue along with a significant reduction in procedure time versus single source injection devices”.
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.