Advamedica’s Hemostat Cleared for Severe Surgical Bleeding

The FDA has granted 510(k) clearance to Advamedica’s Ax-Surgi surgical hemostat to control severe surgical bleeding.

The biopolymer-based device is cleared for temporary control of internal organ space bleeding in patients who experience a minimum of 30 percent loss of total blood volume.

Ax-Surgi is derived from chitosan, a biopolymer sourced from crustaceans that has bioadhesive properties.

The device can also be used for control of severely bleeding wounds, including surgical wounds and traumatic injuries.