Major trauma due to wounds leads to as many as five million deaths each year(1). Most of these deaths are the result of hemorrhaging during surgery: bleeding accounts for about 80% of deaths in the operating theatre(2). This means that stopping blood flow and promoting clotting are vital during surgery. Offering the lowest endotoxin acid porcine skin gelatin available on today’s market, X-Pure is an exceptionally safe gelatin solution for in-body hemostatic use.
X-Pure offers numerous benefits over alternative hemostatic agents. Its key benefits:
- Endotoxin levels(3) below 20 Endotoxin Units per gram (EU/g) or even below LAL analysis detection limits if required
- The world's lowest levels for acid porcine skin gelatin, along with the outstanding foaming properties you can expect from this specific gelatin
- Excellent absorption capacity: gelatin absorbs at least 40 times its own weight of blood and can expand by 200%
- Biocompatible and biodegradable
- Gelatin-based products are fast acting, and non-antigenic
- Easily grindable for syringe application, for instance, if you want to combine gelatin with thrombin
- Suitable for both human and veterinary hemostatic applications
- Gelatin is Generally Recognized As Safe (GRAS) by the USA's Food and Drug Administration (FDA) and compliant with the US, European and Japanese pharmacopeia.
Because of the increase in surgery, the hemostatic market is growing rapidly, with an expected Compound Annual Growth Rate (CAGR) of 6.2% a year from 2015 to 2020(4). At the same time, surgeons need to rely on the best hemostatic agents in order to reduce the number of deaths from hemorrhaging during surgery.
Gelatin is widely employed in hemostat manufacturing, mainly in the form of sponges, strips, powder or (nano) fibers. In 95% of these products acid porcine skin gelatins are used, because of their greater stability and better foaming properties. For a few specific purposes, lime bovine bone gelatins are preferred. With the X-Pure range, Rousselot offers the hemostatic market an acid porcine skin gelatin with an additional key benefit: the lowest endotoxin levels in the world.
Avoiding patient exposure to harmful endotoxins is a major challenge in applying hemostatic solutions, as these bacterial toxins can cause a severe, sometimes fatal, immune response. This means low-endotoxin gelatins offer far greater safety in in-body applications like hemostatics.
X-Pure gelatins for hemostatics are highly purified gelling(5) gelatins, offering endotoxin levels that are unrivalled in the market. Check the table for details on our X-Pure range.
(1) Gaunt T, Wolley C. Continuing Education in Anaesthesia Critical Care & Pain, Volume 14, Issue 6, 1 December 2014, Pages 251–255, doi.org/10.1093/bjaceaccp/mkt065
(3) These levels were determined by means of the Charles River LAL (Limulus Amebocyte Lysate) assay, an FDA-compliant method
(4) MarketsandMarkets Analysis, Hemostats Market by Product Type, 2015-2020
(5) Gelling gelatins according to EP/USP/JP