Devices initially designed for use by military personnel often find their way to the general market: powered exoskeletons for paraplegics are one example. Now the US FDA has granted RevMedX permission to sell its XStat 30 wound dressing, designed to treat gunshot and shrapnel wounds, to civilians as well as soldiers.
XStat 30 is an injector filled with dozens of small sponges, which expand inside the puncture wound to control bleeding. A slightly different version was initially cleared for use on the battlefield in April 2014, but this new 510(k) clearance could vastly expand the potential market.
The device is used to stabilise a haemorrhaging patient long enough to get them to a hospital where they can be treated surgically. The sponges – 92 to a device – are coated with a haemostatic and collectively can absorb around 300ml of blood. They can stay in place for up to four hours but must ultimately be extracted with forceps, so each is sewn with a radiopaque marker to assist removal.
XStat 30 is indicated to control severe life-threatening bleeding from wounds in areas where a tourniquet cannot be placed. It is not indicated for use in certain parts of the chest, abdomen, pelvis or tissue above the collarbone.
The technology’s great virtue is the speed of deployment. Current acute treatment for injuries that cannot be addressed with a tourniquet involves applying gauze and pressure to the surface to staunch the bleeding, which can be awkward and take too much time. Inserting tiny sponges within the puncture itself is intended to stop the bleeding more effectively.
Expansion of the indication will be a fillip for Ohio-based RevMedX. In many countries the majority of incidents in which people are wounded by bullets or shrapnel might be expected to concern serving soldiers in a war zone rather than civilians. This is not true of the US.
More than 57,000 members of the US armed forces have been killed or injured during the 14 years of the Iraq and Afghanistan conflicts, but over 37,000 US civilians have been killed or injured so far in 2015 – and that is solely from gunshots.
Use of the XStat 30 will not be appropriate in all of these incidents. Apart from only being cleared for use in certain areas of the body such as the armpit or groin, it can be used only in adults and adolescents and is therefore of no use in the thousand or so incidents in the US each year when a child is shot.
When the earlier version of the product was under development for military purposes RevMedX said that it would cost around $100. Whether that price will be maintained for the wider market is not known. Perhaps economies of scale might allow the end-user cost to drop. In any case the company’s revenues from the XStat family look set to increase.