Axiostat Chitosan Hemostatic Dressing Gets US FDA Approval

Axiostat has become the first Indian wound care product to receive 510(K) FDA clearance in the US for its external hemostatic dressing. Axiostat, a 100% chitosan haemostatic dressing to stop external bleeding, was earlier approved with CE mark in Europe. The FDA clearance now allows Axiostat to be marketed in the US as over-the-counter (OTC) product for control of bleeding.To get more news about IFAK kits, you can visit rusuntacmed.com official website.

Axiostat Chitosan Hemostatic Dressing is a patented product that has prevented countless deaths due to bleeding in battlefields, hospitals, and on roadsides, worldwide. The innovative first-aid dressing stops uncontrollable bleeding within just two-three minutes of its application. Axiostat is the de-facto product of Indian armed forces.
Axiostat is currently manufactured at their GMP, ISO 13485-certified manufacturing facility in Gujarat. In the US, the product will be marketed by Advamedica Inc, headquartered in Boston.

The bandage is intended as a topical dressing for local management of bleeding but can be used temporarily for severe bleeding of surgical wounds and traumatic injury. The dressing shouldn_t be left in place longer than 24 hours. The bandage appears to be stable at extremes of temperature and doesn_t require special preparation or significant amounts of training for its use. There have been no known allergic reactions attributed to the dressing.

One of the authors has had significant experience with the product in combat care and feels it provides good hemorrhage control in large, open wounds. The material is inflexible, and thus the main disadvantage is difficulty using it in deep, narrow wounds.

In 2006, to address harder to reach, narrow wound track bleeding, HemCon released ChitoFlex, a stuffable, flexible dressing that can be torn or folded. In 2007, HemCon also released a more flexible, enhanced HemCon Bandage line to meet the needs of more narrow wounds.