Controls
Severe bleeding
Ax-Surgi is the first FDA-cleared chitosan-based surgical hemostat.
Surgical Hemostat
Ax-Surgi is the first FDA-cleared chitosan-based surgical hemostat intended for the temporary control of internal organ space bleeding in patients displaying class III or IV bleeding.
USFDA Cleared, 510(k) K213198
Disclaimer: Ax-surgi is a prescription based hemostat and should only be used by trained medical professionals
Ax-surgi application in the controlling abdominal aortic bleeding (grade 4)
Controls severe bleeding
Rapid and higher absorbency leading to significantly control of class III and class IV bleeding.
Strong Bioadhesion
Creates a reversible mechanical seal on the bleeding site.
X-ray detectable
Mitigates the risk of leaving inside the body during intraoperative procedures.
Ready to use
Supplied sterile, no preparation is required.
How to use Ax-Surgi
- Open the pack and remove the Ax-Surgi.
- Apply Ax-Surgi with the non-marked side in contact with the bleeding surface and apply pressure until bleeding is controlled. More than one dressing may be required.
NOTE: If needed, additional gauze or a pressure dressing may be applied to maintain pressure.
- Keep Ax-Surgi till the wound is closed. (surgery is complete).
NOTE: The time for formation of a stable clot may vary depending on several patient factors.
- Irrigate Ax-Surgi with copious amounts of saline and gently remove it from the wound without dislodging the blood clot and repair the bleeding site if required.
Warnings:
- Ax-Surgi is a non-absorbable hemostat and must be removed from the wound prior to wound closure. Do not implant.
- Do not leave Ax-Surgi in place for more than 48 hours.
- Adhesion formation associated with the dressing use was noted in preclinical studies; adhesions were also observed with control materials.
- This device has not yet been tested on patients with compromised coagulation.
Precautions:
- If bleeding persists, additional products may be applied to the wound.
Contraindications:
- The Ax-Surgi is not indicated for use on individuals who are sensitive to or who have an allergic reaction to shellfish.
- Ax-Surgi is not indicated for intraluminal vascular use.
About Us
Advamedica Inc. is a deep science MedTech company established in 2015 and is focused on biomaterial based medical devices for pre-hospital, intra-operative and post-operative clinical needs. The company was founded by Leo Mavely – a bioengineer who along with reputed scientists developed novel biomaterials based medical devices for management of trauma, surgical and chronic-infectious wounds.
