X-Pure for hemostatics

Saving lives in surgery with high-purity hemostatics

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.

Key benefits of X-Pure

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.

The hemostatic market is growing – and demanding higher quality solutions

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.

X-Pure: a new standard in hemostatic applications

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.

Avoid exposure to harmful endotoxins with X-Pure

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.

Interested in manufacturing highly safe hemostatics products for in-body applications?

(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
(2) Ibid
(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