Advamedica Inc announces FDA clearance for Ax-Surgi Surgical Hemostat

Advamedica Inc., a biomaterial focused MedTech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. With this, Ax-Surgi has become first and only chitosan based hemostat cleared for controlling severe surgical bleeding.

Ax-Surgi is based on 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.

“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, President and CEO of Advamedica Inc. 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.

A number of products ranging from standard lap-sponges to absorbable hemostatic patches and sealants are available for the surgical 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.

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 and is composed of a 100% chitosan pad attached to a surgical gauze backing with x-ray detectable grid.
MB Bureau