Axio Biosolutions Gets FDA Clearance For 'Ax-Surgi' Surgical Hemostat
Ax-Surgi is based on a novel biopolymer platform and controls bleeding through its bioadhesive action. It is indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding
Axio Biosolutions, a biomaterial-focused medtech company on Monday informed that the US Food and Drug Administration (FDA) has cleared its latest innovation, Ax-Surgi Surgical Hemostat. With this, Ax-surgi has become the first and only chitosan-based hemostat cleared for controlling severe surgical bleeding, the company said in a statement.
Ax-Surgi is based on a novel biopolymer platform and controls bleeding through its bioadhesive action. It is indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding. It can also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries, the statement said.
“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” said Leo Mavely, Founder and Director of Axio Biosolutions.
A number of products ranging from standard lap-sponges to absorbable hemostatic patches and sealants are available for thrgical bleeding control. Most of these are indicated to control minor bleeding and hence a major challenge for surgeons is to select a suitable hemostat that can be used in different grades of the bleedings.
The company stated that Ax-surgi will fill this gap by offering a rapid-acting hemostat for controlling moderate to severe bleeding from surgical and traumatic injuries. Ax-surgi is a ready-to-use, non-absorbable hemostat.