INFOLINK: Industry News
The FDA recently granted 510(k) clearance to 3M’s (St Paul, Minnesota), Tegaderm Chlorhexidine Gluconate (CHG) I.V. Securement dressing for an expanded indication to reduce catheter-related bloodstream infection. According to the manufacturer, Tegaderm CHG I.V. Securement Dressing is the only transparent dressing indicated and proven to reduce catheter-related bloodstream infection and vascular catheter colonization that aligns with evidence-based guidelines and practice standards. The dressing provides 4 essential elements to cover and protect patients’ catheter sites and secure devices to skin.
Acelity, San Antonio, Texas, announced that its Prevena Duo Incision Management System is now available in the United States. The system is the first single-use negative-pressure wound therapy system designed for the concurrent management of 2 closed surgical incisions, according to the manufacturer. It is configured to help reduce postoperative complications in bilateral procedures, such as vascular harvesting, breast reconstruction, and orthopedic trauma surgeries.
Melinta Therapeutics, New Haven, Connecticut, announced the FDA has approved Baxdela (delafloxacin), indicated in adults for the treatment of acute bacterial skin and skin structure infections caused by susceptible bacteria. The agent is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including methicillin-resistant Staphylococcus aureus, according to the manufacturer. It is available in both intravenous and oral formulations.
ConvaTec, Skillman, New Jersey, recently launched its Flexi-Seal PROTECT Fecal Management System in the United States following FDA 510(k) clearance. The system is the newest addition to the company’s products to manage acute fecal incontinence and to help reduce the associated risks of skin breakdown and spread of Clostridium difficile infection. The indwelling fecal management catheter is intended for use to manage fecal incontinence through the collection of liquid to semiliquid stool and to provide access to administer medications, according to the manufacturer.