The FDA has granted 510(k) clearance to Advamedica’s Ax-Surgi surgical hemostat. It is the first and only chitosan-based hemostat cleared for the controlling of severe surgical bleeding.
The use of traditional dressings to stop a haemorrhage is only effective in treating superficial wounds. When there is substantial bleeding and damage to the skin tissue, it becomes necessary to employ a hemostatic agent1.
Chitosan and its derivatives have been widely used for biomedical applications due to antioxidative, anti-inflammatory, antimicrobial and tissue repair-induced properties2. It also possesses hemostatic properties as it can adhere to red blood cells and encourages platelets to adhere, activate, and aggregate at the site of vascular injury3.
Ax-Surgi is derived from chitosan, a biopolymer from crustaceans that controls bleeding via its bioadhesive properties. It is indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding (patients who experience a minimum of 30% loss of total blood volume). The device can also be used for the control of severely bleeding wounds, for instance, surgical wounds and traumatic injuries4.
The mechanism of action involves the absorption of plasma by the chitosan pad, which results in the physical aggregation of blood cells and clotting factors at the site of application. In addition, when applied with pressure, Ax-Surgi Surgical Hemostat creates a mechanical barrier against bleeding.
Clinical findings: Efficacy and Safety
Ax-Surgi Surgical Hemostat is as safe and as effective as the predicate device, QuikClot Control+ Hemostatic Dressing, which is a kaolin-based hemostatic dressing in its intended use.
In its preliminary pivotal study, Ax-Surgi achieved successful hemostasis in a swine liver resection model displaying class III or class IV bleeding. This study evaluated inflammation, adhesion formation, systemic and local toxicity according to ISO 10993-06 and ISO 10993-11 and the local effect after implantation as compared to the predicate device.
The hemostatic efficacy and safety were compared with the standard of care as the control group. The preclinical studies demonstrated the following for Ax-Surgi:
- Able to achieve hemostasis;
- Can be radiographically detected;
- Inflammation and adhesions associated with the device were as expected for this type of surgery (laparotomy and liver resection) and were substantially equivalent to the standard of care;
- No evidence of vascular obstruction or embolization5.
In view that Ax-Surgi Surgical Hemostat is substantially equivalent to the predicate device, QuikClot Control+ Hemostatic Dressing, 510(k) premarket notification, FDA has granted 510(k) premarket notification clearance to Advamedica’s Ax-Surgi surgical hemostat.
Ax-Surgi thus increases the options in the treatment of haemorrhage by offering a rapid-acting hemostat for controlling moderate to severe bleeding from surgical and traumatic injuries. Ax-Surgi is a non-absorbable, ready-to-use hemostat that is supplied as sterile with no preparation required. It comprises a 100% chitosan pad attached to a surgical gauze backing with a detectable X-ray grid, mitigating the risk of leaving Ax-Surgi inside the body during intraoperative procedures.
References
- Nakielski P, Pierini F. Blood interactions with nano- and microfibers: Recent advances, challenges and applications in nano- and microfibrous hemostatic agents. Acta Biomater. 2019;84:63-76. doi:10.1016/j.actbio.2018.11.029
- Pogorielov M, Kalinkevich O, Deineka V, et al. Haemostatic chitosan coated gauze: in vitro interaction with human blood and in-vivo effectiveness. Biomater Res. 2015;19:22. Published 2015 Nov 2. doi:10.1186/s40824-015-0044-0
- Stricker-Krongrad AH, Alikhassy Z, Matsangos N, et al. Efficacy of Chitosan-Based Dressing for Control of Bleeding in Excisional Wounds. Eplasty. 2018;18:e14. Published 2018 Mar 10.
- Home – AX-surgi. Ax. (2023, April 3). Retrieved from https://ax-surgi.com/
- Ainoa Forteza – accessdata.fda.gov. (n.d.). Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213198.pdf
