Device is intended for use primarily by ICU nurses during infusions in patients in a critical care setting.
PuraCath Medical™, a venture-backed startup company focusing on the development of technologies to reduce infections in patients with intravascular catheters, announced today that it has received 510(k) clearance for its FireFly™ Needleless Connector from the U.S. Food and Drug Administration (FDA). The Firefly™ Needleless Connector is a sterile single patient use connector for needleless access to the IV line and IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration. This regulatory determination by the FDA gives PuraCath clearance to market the FireFly™ needleless connector in the U.S.
“Receiving 510(k) clearance for the FireFly™ Needleless Connector is a major accomplishment for PuraCath™ since it represents the initial regulatory approval in our vascular access product line,” said Julia Rasooly, PuraCath Medical’s CEO. “We believe our approach of using UV light to disinfect IV catheters in hospitals or in outpatient care will provide nurses and caregivers a safe and easy-to-use disinfection tool for reducing CLABSIs during infusions.”
“This is a major step toward eliminating practice variation with needleless connector asepsis,” stated Dr. Gregory Schears, anesthesiologist at Mayo Clinic, and Clinical Advisor to PuraCath™. “This will help ‘engineer in’ compliance and accountability which will further reduce CLABSI.”
PuraCath Medical™ is planning a limited U.S. market release of the FireFly™ Needleless Connector while it continues its initiatives to develop and commercialize additional safe, and user-friendly technologies in this product pipeline which are designed to reduce the risk of infectious complications (CLABSIs) associated with vascular access.
What is a CLABSI (Catheter-Line Associated Bloodstream Infection)?
A CLABSI (Catheter-Line Associated Bloodstream Infection) is a laboratory confirmed bloodstream infection related to a central line such as a central venous catheter, PICC line, midline, etc. CLABSIs are associated with a high-cost burden, accounting for approximately $46,000 per case, due to prolonged hospital stays and increased mortality. More than 250,000 CLABSIs are known to occur annually in the U.S. The most common cause of a CLABSI is due to improper aseptic techniques or lack of compliance to proper aseptic techniques, and improper management of the catheter lines during access.
About PuraCath Medical™
PuraCath Medical™, a Silicon Valley based-company, is dedicated to improving the quality of life of patients by reducing the risk of infections. The Company is utilizing its technology platform, which was spun out of Stanford University’s Biodesign program, to develop novel, easy-to-use devices designed to reduce the risk of infections in patients with catheters in order to decrease infection-related hospitalizations and their associated costs. PuraCath Medical™ has received a prestigious small business government grant from the National Institute of Health (NIH) NIAID division with grant ID Number R43AI134553 and R44AI134553 to support these initiatives.
For more information on PuraCath Medical™, please visit http://www.puracath.com