SAM Medical Products' Junctional Tourniquet Receives 510K Approval to Control Axilla Hemorrhage
July 30, 2013 -- SAM Medical Products is pleased to announce it has received 510(k) regulatory clearance from the FDA to add an additional indication of use to the SAM Junctional Tourniquet (SJT).
The new 510K indication allows the SJT to be used to control difficult bleeds in the axilla area. The device now has three purposes – controlling inguinal hemorrhage, controlling axilla hemorrhage and pelvic fracture stabilization. The additional indication of use propels the SJT to the forefront of battlefield devices of this type, as no other device currently available on the market offers this level of versatility for these three cleared indications.
The SJT is designed to control bleeding where standard tourniquets would not be effective. Such wounds are typically junctional in nature, such as a high level leg or arm amputation as a result of an IED blast injury. Time is of the essence for patients with these types of injuries, and the SJT's simple design allows hemorrhage control in less than 25 seconds in most cases. Pelvic fractures are often associated with these types of injuries, and the SJT also stabilizes pelvic fractures.
"We are pleased to offer additional value to our customers with this new indication" said Adrian Polliack, President of SAM Medical Products. "There's a limited amount of space available for medical devices in military backpacks and emergency vehicles. The SJT provides several life-saving features in a small cube space while being very lightweight. Combat medics and first responders would need to carry three separate devices to treat the same indications that the SJT can do with one."
The SAM Junctional Tourniquet is available for purchase worldwide.
About SAM Medical Products
SAM Medical Products is committed to bringing innovative solutions to market that meet the challenging needs of emergency medicine, the military, and hospitals around the world. The SAM Splint is the gold standard in flexible splinting products, and we take pride in creating quality products that raise the bar. Our product lines focus primarily on fracture management and wound care, and include the SAM Splint, SAM Pelvic Sling II, SAM Soft Shell Splint, Blist-o-Ban, the SAM Chest Seal, and the SAM Casualty Card. Headquartered in Wilsonville, OR, our products are distributed globally in over 60 countries. Find out more at www.sammedical.com.