Product Technology Overview: BloodSTOP™ iX Hemostat by LifeScience Plus, Inc.
by Emily Keeter and James McGuire DPM, PT, CPed, FAPWHc
BloodSTOP iX is an absorbable, bioresorbable, lipophilic, animal-free hemostat, which resembles and is designed to handle like gauze. BloodSTOP iX is composed of etherized oxidized regenerated cellulose, which allows it to be 100% water-soluble with no animal-derived properties. BloodSTOP iX reduces bleeding time and accelerates blood coagulation by activating the intrinsic clotting pathway. Some of the benefits of BloodSTOP iX include its cost-effectiveness, ability to conform to different types of wounds, non-irritating woven matrix, and the reduction in hold times.
How BloodSTOP iX Hemostat Works
There are a few polysaccharide-based hemostatics on the market today. The two main products are either composed of oxidized cellulose or poly-N-acetyl glucosamine.1 BloodSTOP iX is an oxidized cellulose-based product and therefore has the capability to accelerate thrombin generation in the body2, which is necessary for the intrinsic coagulation pathway. The polysaccharide meshwork of the product also works as a framework to support coagulation.3 A major benefit of the BloodSTOP iX product is the ease of removal without the disruption of the clot that has formed underneath.
Animal studies comparing the efficacy of three different hemostatic agents found BloodSTOP iX to be superior. Compared to Surgicel and Gelfoam, BloodSTOP iX had the lowest mean average bleeding time of any of the three products.4
Indicated Uses for BloodSTOP iX
In the United States, BloodSTOP iX currently has an FDA 510K Market clearance that allows it to only be used for surface wounds. BloodSTOP iX works best on small arterial, venous and capillary bleeds. To use, fold in half and apply to the cleaned wound. Apply pressure until bleeding stops. Once BloodSTOP iX absorbs the blood it transforms into a translucent gel. The gel seals the wound creating an optimal healing environment. The translucency of the gel also allows for monitoring of the healing process without removing the matrix. Once the clotting process is complete, the gel can be easily removed by simply rinsing it off. The water-solubility of BloodSTOP iX allows it to be easily removed without disruption of the clot underneath.
In European countries, the product’s Class III CE certification allows for internal and surgical use in a number of procedures including: neurosurgery, thoracic, trauma, gastro-intestinal surgery, plastic surgery, vascular surgeries and ulcer debridement to name a few. BloodSTOP iX is easy to use, cost-effective, and is packaged sterile for one time use.
1. Casey BJ. Blood Coagulation inducing synthetic polymer hydrogel [dissertation]. College Park, MD: University of Maryland; 2010.
2. Rysava J, Dyr JE, Homola J, et al. Surface interactions of oxidized cellulose with fibrin(ogen) and blood platelets. Sensors and Actuators B: Chemical. 2003;90:243-249.
3. Larson PO. Topical Hemostatic Agents for Dermatologic Surgery. Journal of Dermatologic Surgery and Oncology. 1988;14(6):623-632.
4. Ferretti L, Qiu X, Villalta J, Lin G. Efficacy of BloodSTOP IX, Surgicel, and Gelfoam in Rat Models of Active Bleeding From Partial Nephrectomy and Aortic Needle Injury. Urology. 2012;80(5):1161.e1–1161.e6.
About the Authors:
Emily Keeter is a second year student at Temple University School of Podiatric Medicine (TUSPM) in Philadelphia, Pennsylvania. She graduated from the University of Florida with a Bachelor of Science in Nutritional Sciences.
Dr. James McGuire is the director of the Leonard S. Abrams Center for Advanced Wound Healing and an associate professor of the Department of Podiatric Medicine and Orthopedics at the Temple University School of Podiatric Medicine in Philadelphia.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.