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RyMed Technologies Receives FDA Clearance for InVision-Plus CS Needleless IV Connector
8/10/2010 6:45:27 AM
FRANKLIN, Tenn.--(BUSINESS WIRE)--RyMed Technologies announced today that it has received FDA 510(k) clearance for its newest IV connector, InVision-Plus® CS™ with Chlorhexidine-Silver Ion Engineering.
The InVision-Plus CS is the only needleless IV connector to offer the combined antibacterial protection of chlorhexidine and silver – providing a septum that is impregnated with chlorhexidine and silver ions, and a silver-impregnated fluid pathway. This antibacterial protection encompasses both the fluid spike and the catheter hub.
The InVision-Plus CS connector combines chlorhexidine and silver impregnation with the proven design features of the InVision-Plus® with Neutral Advantage™ technology. Among the new features of the neutral/zero fluid displacement CS connector is a housing that allows clinicians to view the interior of the device.
The FDA clearance notes that the CS “has been shown to be effective for seven days” against eight different microorganisms. All eight organisms are commonly associated with catheter-related bloodstream infections (CR-BSI). The InVision-Plus CS is also designed to be the easiest needleless IV connector to disinfect, flush, care for, and maintain.
“The FDA’s rapid clearance of our new CS connector gives the healthcare community a much-needed weapon in the fight against CR-BSI,” said Dana Ryan, RyMed’s President and CEO. “Separately, both chlorhexidine and silver have a long history of being safe and effective. CS is the first needleless connector to combine them in a device that also has the demonstrated advantage of zero fluid displacement.”
CR-BSI, one of the most frequent and deadly healthcare-acquired infections, kills 30,000 patients a year in the U.S.
A scientific poster presented at the 2010 annual conference of the Society for Healthcare Epidemiology of America (SHEA) showed the InVision-Plus CS connector significantly outperformed another manufacturer’s silver-coated connector in preventing bacterial contamination.
“We have data supporting a 7-log reduction of MRSA for up to seven days,” said Ryan. “Because of this long-lasting effectiveness, we believe CS will greatly increase RyMed’s presence in the long-term care and home infusion markets.
“Given the FDA’s recent action requiring closer study of positive-pressure connectors -- which are associated with increased infections -- InVision-Plus CS means that institutions desiring to move away from other, risky connectors have something safe and effective to turn to,” Ryan said.
The FDA clearance for InVision-Plus CS also includes clearance for the device to be used with power injectors such as those used in CT scans.
About RyMed Technologies, Inc.
It is believed that RyMed Technologies, Inc. is the only maker of needleless IV connectors that is not required by the FDA to conduct post-market studies of its connectors. RyMed makes only zero-fluid-displacement (neutral-pressure) connectors, such as the InVision-Plus with Neutral Advantage.
Founded in 1994, RyMed Technologies specializes in the development and marketing of innovative safety products in the field of intravenous catheter care management. The company’s products are designed to help reduce catheter-related infections associated with vascular access, addressing a $5 billion-plus market.
The company is headquartered in Franklin, Tenn. For more information, call (615) 790-8093 or access www.rymedtech.com.