BloodSTOP® and BloodSTOP® iX are biocompatible, non-irritating, woven matrices of fibers made from natural plant compounds. They adhere to a wound, initiate blood coagulation, stop bleeding, and form a protective layer to create an optimal environment for wound healing. Their water solubility allows for removal by rinsing, without disruption of a clotted surface.
Efficacy Studies of BloodSTOP® iX as compared with Surgicel® and Gelfoam®
UCSF Preclinical Study Done in Conjunction with University Hospital Pellegrin in France Shows BloodSTOP iX® Controls Bleeding Up To Three Times Faster Than Gelfoam or Surgicel
Using a rat model of partial nephrectomy and aortic needle injury the three different hemostatic agents were compared to assess the time needed to control bleeding. The results showed BloodSTOP iX produced a statistically significant reduction in the time needed to control bleeding in comparison to the other two agents.
A recent preclinical study was conducted at the Knuppe Molecular Urology Laboratory, University of California at San Francisco. The investigators utilized a rodent model performing partial nephrectomy and aortic needle injuries; time required to stop bleeding for three hemostatic agents (BloodSTOP iX, Surgicel and Gelfoam) was measured. The results published in the August issue of Urology magazine demonstrated that BloodSTOP iX produced a statistically significant advantage over the other two agents.
The study was conducted in conjunction with the University of California at San Francisco School of Medicine and The University Hospital Pellegrin, Bordeaux, France. The study was spearheaded by Ludovic Ferretti, M.D. Ph.D., University Hospital Pellegrin, Bordeaux, France, and University of California at San Francisco School of Medicine; Jacqueline D. Villalta, M.D., University of California at San Francisco School of Medicine; Guiting Lin, M.D., Ph.D., Department of Urology University of California at San Francisco School of Medicine; Xuefeng Qiu, M.D., Institute of Cardiovascular Disease & Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, China.
"This study is significant because of the increasing use of topical hemostatic agents in surgical procedures," said Vicky Feng, CEO of LifeScience PLUS. "This is the first new study that will help guide surgeons in their choice of which agent to use for topical bleeding. Now we have a published study that shows BloodSTOP iX is effective and faster acting, up to three times faster, for the control of bleeding than two of the most well known hemostats on the market."
In the first part of this two-part study a bilateral partial nephrectomy was performed in 20 rats without the aid of mechanical hemostatic devices. BloodSTOP iX was applied to the wound in 10 rats while the other 10 were treated with Surgicel. Finger pressure was applied until bleeding stopped and then released to monitor the presence of active bleeding for five minutes. The mean bleeding time with BloodSTOP iX was 83.70 +/- 13.73 seconds versus 168.8 +/- 19.41 seconds for Surgicel showing BloodSTOP iX to be twice as fast in controlling bleeding.
In the second part of the study 24 rats underwent aortic injury with a 25-gauge needle puncture. Gelfoam, Surgicel and BloodSTOP iX were applied to the site and bleeding time was monitored using the same model as the partial nephrectomy. Once again BloodSTOP iX (66.0 +/- 13.74 seconds) proved to be significantly faster at stopping bleeding than Gelfoam (157.5 +/- 31.44 seconds) and Surgicel (187.5 +/- 23.20 seconds).
"This study shows conclusively that BloodSTOP iX is the fastest in controlling bleeding when compared to Surgicel or Gelfoam," added Feng. "We are very excited about the outcome of this study and hope that it will help others realize the superior nature of this product."
BloodSTOP iX is an etherized and oxidized regenerated cellulose matrix that uses a natural coagulation pathway to achieve homeostasis.
About LifeScience PLUS
LifeScience PLUS Inc. (LSP) is a medical device company committed to developing and marketing innovative next-generation wound care technology. Through their line of BloodSTOP(R) wound care products, they have created a unique, all natural, and revolutionary hemostatic matrix. BloodSTOP(R) is a highly absorbent, plant-derived, hydrophilic material that, when properly applied, will actively aid blood coagulation and create a physical barrier and an environment for improved wound healing. These products have received FDA 510(k) marketing clearance and CE Mark approvals as well as achieved landmark results in scientific research and consumer use. The products are currently sold in two versions, BloodSTOP(R) for OTC and BloodSTOP iX(R) for medical professional applications. LifeScience PLUS and BloodSTOP Hemostatic Gauze is dedicated to making a major positive impact on the lives of people with bleeding problems worldwide.