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= SAM® =

Sustained Acoustic Medicine, otherwise known as SAM®, is a wearable device that provides low intensity, long duration ultrasound treatment. Developed by ZetrOZ Systems, a medical device company located in Trumbull, CT, SAM® is a therapeutic ultrasound device that is FDA approved to accelerate tissue healing and relieve chronic pain.

Applications of Therapeutic Ultrasound
Ultrasound is a form of high-frequency, non-ionizing acoustic radiation that produces mechanical waves with a frequency above 20 kHz. Therapeutic ultrasound initiates mechanotransductive, thermal, and cavitation effects and typically utilizes frequencies between 1 MHz and 3 MHz. The level of resistance that a sound wave experiences by propagating through a medium is known as impedance. During therapeutic ultrasound treatments, the impedance of the affected tissue is mostly determined by its density and elasticity.

Mechanotransduction assists in the regeneration of the extracellular matrix and the activation of multiple biological pathways, while thermal effects increase tissue plasticity, rate of nutrient transport, vasodilation, and removal of cellular waste products. The changes in pressure that are caused by acoustic waves also promote cavitation in the plasma membrane, which increases cell permeability and facilitates drug delivery. Evidence also suggests that ultrasound delays the pain and degeneration associated with inflammation.

Continuous vs. Pulsed Ultrasound
Therapeutic ultrasound waves are typically applied to the affected tissue in either a continuous or pulsed manner. Low-intensity continuous ultrasound (LICUS) is applied as a constant ultrasound wave (100% duty cycle), while low-intensity pulsed ultrasound (LIPUS) is applied through ON and OFF duty cycles. The duty cycle is the only major differentiating factor between LICUS and LIPUS.

LICUS provides a constant ultrasound stimulus that produces heat to stimulate tissue regeneration, alter membrane permeability, and regulate intercellular and molecular pathways. In contrast, pulsed ultrasound, which applies the ultrasound treatment in successive bursts, produces non-thermal effects that increase tissue metabolism, enhance fibrous tissue extensibility, and elevate pain threshold.

Sustained Acoustic Medicine
Sustained Acoustic Medicine (SAM®) is an FDA-approved class-II, home-use medical device that delivers LICUS (3 MHz, 1.3 W, 132 mW/cm2) for 4 hours. SAM® devices come with a power controller containing a rechargeable battery, applicator containing a transducer encasing a piezoelectric crystal, and ultrasound coupling patches.

Technical Information
Commercially available SAM® treatments utilize an integrated, closed-loop, 3.7 V device that contains parallel low-impedance circuitry, two transducers with coupling interfaces, and closed-loop feedback control. These components are housed in a welded acrylonitrile butadiene styrene shell and powered by a lithium polymer battery. Each transducer possesses a uniform effective radiating area of 5 cm2. SAM® transducers contain a 10° diverging lens made from polymethylpentene that disperses the acoustic energy entering an application site. These features maximize acoustic streaming in tissues while minimizing focal regions, hot spots, and standing waves. Each transducer covers a volume of 58 cm3 and a depth of 5 cm. The echogenic transducer also assesses the coupling through real-time feedback. SAM® devices are secured to the application site with a biocompatible, nonwoven material. This material contains a reservoir that stores the ultrasound transducer and provides a connection between the SAM® device and the coupling gel.

SAM® Applications
The SAM® devices treat the following affected areas:
 * Neck: Cervical pain, neck spasms
 * Upper back: Trapezius pain, back spasms
 * Shoulder: Chronic shoulder tendonitis, acromial pain, frozen shoulder, acromioclavicular joint (AC joint) sprain, clavicle fracture
 * Arm: Bicep tendonitis, lateral epicondylitis, medial epicondylitis, forearm strain
 * Abdominal: Oblique strain
 * Hand: Carpal tunnel syndrome
 * Lower back: Sciatic pain
 * Hip: Coxal pain, abductor strain, adductor strain
 * Upper leg: Quadricep strain, quadricep tendonitis, upper hamstring strain, upper hamstring partial tear, mid-hamstring strain, mid-hamstring partial tear, lower hamstring strain, lower hamstring partial tear
 * Knee: Patellar pain, osteoarthritis, meniscus tear, knee hyperextension, medial collateral ligament (MCL) sprain
 * Lower leg: Calf strain
 * Ankle: Ankle sprain, frayed Achilles tendon, post-operation Achilles recovery
 * Foot: Metatarsal stress fracture, plantar fasciitis

Optimal Use of SAM®
Clinical ultrasound treatment has been used for decades, but its application by trained technicians has been limited to 2-3 weekly sessions of 5-20 minutes. SAM® has the ability to be used without visits to rehabilitation or physician centers because it is available to use at the patient’s convenience.

Optimal delivery of therapeutic ultrasound is achieved by self-administering treatment. By reducing the intensity of the ultrasound waves to less than 150 mW/cm2, SAM® can be applied over four hours; this technique, referred to as low-intensity continuous ultrasound (LICUS), mitigates most of the risks of thermal injury.

Based on previous clinical trials, there is a consensus that therapeutic ultrasound provides the most significant benefits when at least 4,000 J of energy are applied to the site of injury. Greater amounts of energy increase the effects of the body when exposed to ultrasound waves; additionally, this amount of energy is most beneficial when applied daily. SAM® devices can deliver as much as 18,720 J of acoustic energy, which facilitates pain reduction and the healing of tissue.

SAM® is useful for managing chronic musculoskeletal pain, but its benefits largely depend on the compliance of the patient. Data indicates that SAM® reduces chronic pain, but the amount of pain is significantly reduced when it is used in conjunction with traditional physical therapy, exercise, and rehabilitation efforts.

Assistance of SAM®
Chronic pain management is a complex disorder, and most of the current treatments involve either non-steroidal anti-inflammatory drugs (NSAIDS) or opioid-based medications with long term adverse effects. The diathermic properties of SAM® increase the area of localized, treated tissue, which has an established clinical efficacy for alleviating dorsal pain and treating soft tissue injuries, spasms, and strains. Furthermore, multi-hour treatment reduces pain by increasing skin permeability and tissue regeneration.

There are several different applications of SAM® to optimize drug delivery. By increasing the permeability of the skin, SAM® allows drugs to penetrate deeper into the tissue, an effect that enhances targeted drug delivery and decreases adverse effects of NSAIDs. This phenomenon, known as sonophoresis, could serve as a possible treatment for pathologic conditions like arthritis.

SAM® Products
SAM® products are developed and researched under multiple government funding partners including the US Department of Defense, National Institute of Health (NIH), National Space Biomedical Research Institute (NSBRI), and the National Science Foundation (NSF). All SAM® products are also approved by the Food and Drug Administration (FDA) and CE marked.

SAM® devices are commonly used by both the American military and sporting organizations. The SAM® Pro 2.0 and SAM® Sport have helped treat over 24 million military members and are featured in American football, baseball, basketball, soccer, and numerous other sports.

SAM® is prescription only and can have short-term and long-term adverse effects if used improperly. SAM® products should not be used over the eyes, reproductive organs, brain, spinal cord, or any malignant regions. Additionally, pregnant users should not attach the device over the uterus, users with a pacemaker should not attach the device over the thoracic region of the body, and users with vascular disease should not attach the device over ischemic tissue.

SAM® Sport
The SAM® Sport is a wearable medical device that is designed to increase the circulation of oxygen and nutrients and remove waste products such as lactic acid from the site of a musculoskeletal injury. The SAM® Sport is the first device in the SAM® product line.

SAM® Pro 2.0
Released after the SAM® Sport, the SAM® Pro 2.0 is a wearable medical device that has been approved by the Department of Veterans Affairs to treat chronic pain and musculoskeletal injuries with daily, 4-hour treatments. The major difference between the SAM® Pro 2.0 and the SAM® Sport is the recharge time: the SAM® Pro 2.0 recharges in 4 hours, whereas the SAM® Sport recharges in 8 hours. Military personnel can purchase the device, which is on the Distribution and Pricing Agreement with Optimal Max, through MedLog Solutions, a veteran-owned business that is verified by the Center for Verification and Evaluation (CVE).