FDA Approves DefenCath® (taurolidine and heparin) to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients
CorMedix Inc has announced that the U.S. Food and Drug Administration has approved DefenCath (taurolidine and heparin) catheter lock solution (CLS).
DefenCath has been shown to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSIs by up to 71% in a Phase 3 clinical study.
Catheter-related bloodstream infections are common in patients with central venous catheters. Approximately 80% of patients starting hemodialysis will have a CVC inserted for vascular access. CRBSI’s can occur in up to a third of HD-CVC patients. Each year, ~250,000 CRBSIs occur in patients with an intravascular device, such as central venous catheters (CVCs), leading to death in about one in four patients infected. CRBSIs can lead to more hospital admissions, longer stays, and long-term complications such as cardiovascular events.
