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February 12, 2010

To whom it may concern: Even in todays world of modern medicine, a need for improved fracture response systems designed for patients with extremity injuries still exists. This is especially true when a patient may require transport of a variable time and distance to a place where definitive care can be rendered. Emergency and military personnel are often faced with the challenge of rapidly immobilizing injuries and preparing patients for transfer to a facility many miles away. Limited medical equipment and potentially harsh rural or urban environments are constant predicaments that these first-responders must be equipped to handle. When definitive medical treatment is hours or even days away, management of a patients stress and pain levels becomes critical to their survivability. Unstable fractures and dislocations of the extremities, often complicated by open wounds, add insult to injury by multiplying the overall stress of the patient. Increased bleeding, muscle spasms, edema and pain are the hallmarks of unstable and non-immobilized osseous injuries. Many of these patients are already in a state of circulatory and psychological shock. Timely and appropriate stabilization of extremity injuries decreases additional trauma to the patient and reduces the potential for development of the systemic inflammatory response syndrome (SIRS), a well-documented complication in trauma patients with multiple injuries. Commonly utilized equipment for stabilizing extremity injuries is deficient in providing medical personnel the appropriate tools to effectively manage these patients. Many fracture response systems and splinting devices in service today are limited in scope, complicated to apply rapidly, difficult to transport, and often require redundant equipment levels. A system that allows for rapid and safe application, multiple use capability, and easy transport is essential for todays extreme rescue environments. Minto Research & Development has been hard at work for nearly 3 decades to produce such a fracture response system. Since 1979 Minto has been manufacturing the Sager femoral traction splint. Its worldwide acceptance and use has become the gold standard for the initial treatment of femoral shaft fractures managed in the field. Currently, over 80,000 Sager traction splints are in widespread use in both civilian and military emergency medical operations. Realizing the need for a comprehensive splinting system that could address more than just femur fractures, Minto developed the SEFRS (Sager Emergency Fracture Response System). This product was released in 2005 and is currently in use by emergency medical services and the United States Air Force. To further address the needs of ultimate portability and versatility, the SEFRS was evolved into an even more compact system called the STORM (Sager Tactical Orthopedic Response Matrix). It was brought to market in 2007, primarily for use in military medical operations. Both the SEFRS and the STORM function as multi-use packs, allowing the first-responder to treat multiple injuries on a single patient or even treat more than one patient. They allow rapid

splinting of any fracture or dislocation of the foot, ankle, tibia, knee, femur, hand, wrist, forearm, elbow, humerus, or shoulder in both children and adults, regardless of patient size or body mass index. All SEFRS and STORM sets are equipped with 3 interoperable components: the Sager femoral traction splint, the Adaptor, and the Tensor Cravats. The cornerstone of these fracture systems is the Adaptor. This revolutionary device allows rapid, one-person assembly and application, provides infinite treatment possibilities, and functions synergistically with a redesigned, compact version of the proven Sager traction splint. The multifunction Tensor Cravats complete these interoperable components by allowing safe and secure immobilization of extremity injuries while providing broad antimicrobial coverage of open wounds. The possible applications of these systems are limited only by the imagination of the care provider. Also included in these sets are the versatile SAM splints that can be used to rapidly immobilize a wide variety of fractures. The traditional Sager femoral traction splint has been updated and modified into an extremely compact and lightweight model. It can be used for unilateral or bilateral, midshaft or proximal femur fractures. Assembly and application of the splint can be performed by one person in less than two minutes. It the most anatomically fitting femur splint on the market. By providing traction against the ischial tuberosity with the padded articulating base, pressure on the sciatic nerve and proximal vasculature is avoided. There are no half-rings or circumferential components to the proximal portion of the splint. The design of the splint with its straight, in-line traction also prevents increased angulation at the fracture site. When in place, it rests medial to the lower extremities and inside the body silhouette, making it ideal for patient transport. Its radiolucent design allows it to be left in place for unobstructed obtaining and interpretation of xrays. The hallmark of the Sager splint is its use of quantifiable and dynamic traction. It is the only product on the market that continuously shows the exact amount of traction being applied to the leg. Up to 30 pounds (14kg) of traction can be registered on the splint. Its unique dynamic feature allows automatic adjustments in the length of the splint to maintain the pre-set amount of traction regardless of the position of the patients lower extremity or the amount of muscle spasm affecting the fracture. With the Sager splint, complications associated with excess traction or damage to proximal neurovascular structures are avoided. Construction with durable, composite plastic allows years of use and make the splint practically indestructible. The capability to treat any fracture or dislocation of the upper or lower extremities is provided by the universal Adaptor. This device can be assembled in under 15 seconds and applied in a virtually pain-free fashion in less than one minute. Its multi-plane articulating knobs allow rotation of 30 to 330 degrees to match any injury presentation. The extender shafts provide additional and adjustable length to match the patients anatomy. Creation of the splint is performed away from the patient and then applied to a joint or deformity. This allows immobilization of an injury in the position it is found and avoids painful manipulation of the extremity. The splint can be applied to the top of, behind, or along the side of the limb depending of the position of the patient or the preference of the first responder. The possible configurations are endless. Durable plastic and closed cell foam padding make the Adaptor comfortable and safe. It does not absorb fluids and it is easily cleaned and decontaminated, allowing for many years of use.

The Tensor Cravats complete the system by safely immobilizing the injury to the Adaptor or securing the lower extremities to the Sager traction splint. They are made of non-abrasive, elasticized foam and come in multiple widths and lengths, ensuring a universal fit. Many extremity injuries have associated open wounds that require immediate coverage.

Recognizing the need for broad antimicrobial neutralization and wound management, the Tensor Cravats have been topically coated with silver chloride nanocrystals (Slivertec), a known bactericidal agent. They sustain release of silver ions for up to 7 days and can be washed and reused up to 30 times without losing effectiveness. They are odorless, breathable, and latexfree and will wick away moisture, allowing them to stay secure and in place. The Tensor Cravats also provide an instant bandage for safe compression of bleeding wounds, binding over sterile dressings, and splinting of flailing chest injuries. Also included in the STORM system are the non-stretch Security Cravats. These cravats provide secure, firm restriction of extremity motion in the event that a patient becomes overly agitated or distressed. In summary, the treatment capabilities provided by the SEFRS and STORM units are a much needed improvement over current splinting systems available on the market. The ability to manage fractures, dislocations and open wounds of both upper and lower extremities is a must for emergency medical personnel, both in civilian and military operations. These units are compact and very portable. The components are durable and should provide for years of use even in the most extreme environments. Rapid one-person assembly and application set the stage for tactical fracture response scenarios. I personally recommend that the SEFRS and STORM units be incorporated into existing emergency medical operations. They are a huge improvement over current single purpose systems. In my opinion, they represent the latest technology available on the market today. Any first responder faced with the challenge of a traumatized patient with unstable extremity injuries requiring immobilization will find these tools an invaluable part of their treatment regime. Please do not hesitate to contact me for any questions or comments regarding these revolutionary products.

Aaron Osborne, D.O. President, Orthopaedic Trauma Solutions, Inc. Medical Director of Orthopaedic Trauma Mercy Medical Center Redding