GuardIVa Antimicrobial Hemostatic IV Dressing Obtains Additional FDA Clearance

GUARDIVA (chlorhexidine gluconate) antimicrobial hemostatic IV dressing by HemCon
GUARDIVA (chlorhexidine gluconate) antimicrobial hemostatic IV dressing by HemCon

HemCon Medical Technologies announced receiving an additional U.S. regulatory clearance for the antimicrobial hemostatic IV dressing GuardIVa.

As part of its expanded cleared product information, GuardIVa is now supported by data demonstrating that the dressing does not adversely affect normal site healing and has a normal irritation response to chlorhexidine gluconate (CHG) when compared to other commercially available CHG based dressings, which were found to adversely affect healing. GuardIVa also demonstrated the ability to suppress skin flora re-growth for up to ten days, maintaining skin flora at a level equivalent to that observed immediately following pre-operative skin preparation.

In addition, the Centers for Medicare and Medicaid Services (CMS) also confirmed GuardIVa's HCPCS reimbursement codes for Durable Medical Equipment. These codes are used by Medicare and monitored by CMS, and allow wound dressings and other medical supplies to be tracked for reimbursement. The addition of reimbursement codes assures that patients and their providers will now be reimbursed for the use of GuardIVa.

GuardIVa Antimicrobial Hemostatic IV Dressing is an adjunct to infection control measures by providing sustained IV site protection. The dressing is a flexible, absorptive sponge disk that can be easily placed around catheters to absorb exudate, cover and protect sites such as central venous catheters (CVC) and peripherally inserted central catheters (PICC).

GuardIVa contains chlorhexidine gluconate. The CHG antimicrobial agent protects the dressing from microbial colonization and provides sustained effectiveness over seven days against a wide range of microorganisms. GuardIVa is the only IV site dressing on the market that is indicated for control of surface bleeding via HemCon's proprietary hemostatic agent, microdispersed oxidized cellulose.

For more information visit www.hemcon.com.