SAM Medical Products Gets 510(k) Clearance for New Product to Control Junctional Hemorrhage
4/3/2013 11:39:14 AM
WILSONVILLE, Ore., April 3, 2013 /PRNewswire-iReach/ -- SAM Medical Products is pleased to announce it has received 510(k) regulatory clearance from the FDA for the release for sale of the SAM Junctional Tourniquet (SJT). Building upon the highly successful SAM Pelvic Sling II presently utilized by health care professionals around the world to immobilize pelvic fractures, the SJT is designed to also control bleeding where standard tourniquets would not be effective. Such wounds are typically junctional in nature, such as a high level leg 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 application (in standard industry training models) for hemorrhage control in less than 25 seconds in most cases. Compact and lightweight, it can easily be carried in a medical bag or attached to a backpack.
Recent studies indicate that junctional hemorrhage accounts for up to 20% of preventable deaths in combat.1 The SAM Junctional Tourniquet was designed, using input from key military medical personnel, to treat these injuries by placing pressure on an artery to stop the flow of blood to a region of the body. The trademarked and patent pending innovative design utilizes a rugged Target Compression Device (TCD) which, once targeted by the medic, is inflated to apply the necessary amount of pressure. Each SJT can utilize up to two TCD's to treat bilateral injuries. The unique combination of both a mechanical belt buckle and a pneumatic TCD allow for quick application and effective, expedient hemorrhage control.
"We designed the SAM Junctional Tourniquet as an easy to use, multi-purpose product that can be applied quickly in life-threatening situations" said Adrian Polliack, President of SAM Medical Products. "We worked directly with key military medical and scientific personnel along the product development and testing pathway to ensure the product met the rigid requirements associated with medical devices used in the challenging combat battlefield arena. Initial feedback to our approach has been positive, and we are pleased to introduce this life-saving device to the market."
The SAM Junctional Tourniquet is available for purchase on April 2, 2013 domestically, and April 27, 2013 worldwide.
1 Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen- Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): Implications for the future of combat casualty care.J Trauma Acute Care Surg. 2012 Dec; 73(6 Suppl 5):S431-7.
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.
Tanya Stricker, SAM Medical Products, 5036935474, firstname.lastname@example.org
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SOURCE SAM Medical Products