Sam Brusco, Associate Editor03.21.23
Advamedica, a biomaterial-focused medtech startup, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ax-Surgi surgical hemostat. According to the company, Ax-Surgi is the first and only chitosan-based hemostat cleared to control severe surgical bleeding.
Ax-Surgi is based on a novel biopolymer platform and controls bleeding via bioadhesive action. It’s indicated for temporary control of internal organ space bleeding for patients experience Class III or Class IV bleeding. It can also be used to control severely bleeding wounds like surgical wounds and traumatic injuries.
"We are very glad to receive this first of its kind clearance for a chitosan based hemostat for surgical indication which can help surgeons to control severe bleeding in many difficult surgeries and prevent blood loss," Leo Mavely, president and CEO of Advamedica told the press. “As the healthcare costs continue to rise, surgeons are looking for effective measures to reduce the duration of surgeries. These factors are propelling the demand for better and cost-effective solutions for controlling severe bleeding during the surgeries.”
Products ranging from standard lap-sponges to absorbable hemostatic patches and sealants are available already for surgical bleeding control but most are indicated to control minor bleeding. Ax-Surgi will fill this gap; the 100% chitosan pad is attached to a surgical gauze backing with an x-ray detectable grid.
Ax-Surgi is based on a novel biopolymer platform and controls bleeding via bioadhesive action. It’s indicated for temporary control of internal organ space bleeding for patients experience Class III or Class IV bleeding. It can also be used to control severely bleeding wounds like surgical wounds and traumatic injuries.
"We are very glad to receive this first of its kind clearance for a chitosan based hemostat for surgical indication which can help surgeons to control severe bleeding in many difficult surgeries and prevent blood loss," Leo Mavely, president and CEO of Advamedica told the press. “As the healthcare costs continue to rise, surgeons are looking for effective measures to reduce the duration of surgeries. These factors are propelling the demand for better and cost-effective solutions for controlling severe bleeding during the surgeries.”
Products ranging from standard lap-sponges to absorbable hemostatic patches and sealants are available already for surgical bleeding control but most are indicated to control minor bleeding. Ax-Surgi will fill this gap; the 100% chitosan pad is attached to a surgical gauze backing with an x-ray detectable grid.