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LifePatch HeavyTM Severe Bleeding Hemostat
Problem: The high volume and pressure of brisk bleeding overwhelms available absorbable hemostats and hemostatic sealants. Traditional surgical techniques of achieving hemostasis are simply incapable of stopping severe bleeding in a manner that prevents rebleeding. As a result, approximately one million US patients per year face significant risk of death from insufficient surgical hemostasis. One quarter of these patients, in particular, suffer from severe bleeding that can be characterized as difficult to control because current techniques and devices do not adequately stop the bleeding during surgery. The current variable success rate in severe bleeding closure frequently results in post-operative hemorrhage, which is particularly dangerous as failure to stop bleeding within 24 hours is nearly uniformly fatal and accounts for >50% of post-surgical fatalities.
Solution: LifePatch HeavyTM is comprised of a matrix containing LifeBond sealant components lyophilized onto a biodegradable patch backing. The adhesive components are reconstituted when LifePatch HeavyTM is applied to a wound site and undergo cross-linking to form a strongly adhesive gel that closes the wound. The patch backing provides strong mechanical support for the adhesive components and allow for the application of manual pressure on the wound site as the adhesive components cure to form a gel. This enables LifePatch HeavyTM to rapidly effect strong hemostasis even when applied to a severely bleeding injury site. The hemostat can be left in place to reabsorb over a period of several weeks.
Competition: The only absorbable hemostats capable of providing severe hemorrhage control are fibrin-based dressing, variations of which have been developed commercially and by the Red Cross. However fibrin dressings are extremely expensive to produce, have limited shelf lives, and are not entirely free from viral risk as they rely on pooled human blood. |