Business Wire10.10.16
Teleflex Incorporated, a global provider of medical devices for critical care and surgery, has announced it has received FDA 510(k) clearance to market its Arrow JACC with Chlorag+ard Technology and TightTrack tunneler.
Arrow JACC with Chlorag+ard Technology is a long-term, tunneled, small french size antithrombogenic1 and antimicrobial2 central venous catheter designed to meet the needs of patients throughout their course of therapy or illness. The catheter is also designed for use with high-pressure injection for diagnostic studies. The Arrow JACC with Chlorag+ard Technology protects against catheter occlusion3, phlebitis4, and intimal hyperplasia4 for up to 30 days. The Arrow JACC with Chlorag+ard Technology will enable caregivers to effectively and economically preserve vessel access, and care for millions of end stage renal disease patients.
“At Teleflex, we are committed to providing the right line for the right patient at the right time,” said Jay White, President of the Vascular Division. “We are proud to add the tunneled Arrow JACC to our line of vascular access products. By providing an antithromogenic1 and antimicrobial2 catheter that protects against catheter occlusion3, we are offering a technology that no one else can. This is especially important in patients with end stage renal disease where vessel health and preservation is essential to provide a future dialysis vascular access5.”
References
1Data on file. AS compared to uncoated catheters, intravascular ovine model inoculated with Staph aureus. No correlation between in vitro/in vivo testing methods and clinical outcomes have currently been ascertained.
2In vitro data on file 2010. No correlation between in vitro/in vivo testing methods and clinical outcomes have currently been ascertained.
3Occlusion - As compared to uncoated PICCs, in vitro model measuring flush pressure post exposure to human blood. No correlation between in vitro/in vivo testing methods and clinical outcomes have currently been ascertained.
4Phlebitis and Intimal Hyperplasia - As compared to uncoated PICCs, intravascular ovine model. No correlation between in vitro/in vivo testing methods and clinical outcomes have currently been ascertained.
5KDOQI Guidelines 2006.
Arrow JACC with Chlorag+ard Technology is a long-term, tunneled, small french size antithrombogenic1 and antimicrobial2 central venous catheter designed to meet the needs of patients throughout their course of therapy or illness. The catheter is also designed for use with high-pressure injection for diagnostic studies. The Arrow JACC with Chlorag+ard Technology protects against catheter occlusion3, phlebitis4, and intimal hyperplasia4 for up to 30 days. The Arrow JACC with Chlorag+ard Technology will enable caregivers to effectively and economically preserve vessel access, and care for millions of end stage renal disease patients.
“At Teleflex, we are committed to providing the right line for the right patient at the right time,” said Jay White, President of the Vascular Division. “We are proud to add the tunneled Arrow JACC to our line of vascular access products. By providing an antithromogenic1 and antimicrobial2 catheter that protects against catheter occlusion3, we are offering a technology that no one else can. This is especially important in patients with end stage renal disease where vessel health and preservation is essential to provide a future dialysis vascular access5.”
References
1Data on file. AS compared to uncoated catheters, intravascular ovine model inoculated with Staph aureus. No correlation between in vitro/in vivo testing methods and clinical outcomes have currently been ascertained.
2In vitro data on file 2010. No correlation between in vitro/in vivo testing methods and clinical outcomes have currently been ascertained.
3Occlusion - As compared to uncoated PICCs, in vitro model measuring flush pressure post exposure to human blood. No correlation between in vitro/in vivo testing methods and clinical outcomes have currently been ascertained.
4Phlebitis and Intimal Hyperplasia - As compared to uncoated PICCs, intravascular ovine model. No correlation between in vitro/in vivo testing methods and clinical outcomes have currently been ascertained.
5KDOQI Guidelines 2006.