DESCRIPTION
Low-frequency ultrasound in the kilohertz (KHz) range may improve wound healing. Several devices are available, including the MIST Therapy® system, which delivers ultrasonic energy to wounds via a saline mist without direct skin contact.
Ultrasound is defined as a mechanical vibration above the upper threshold of human hearing (greater than 20 KHz). Ultrasound (US) in the MHz range (1–3 MHz) has been used for the treatment of musculoskeletal disorders, primarily by physical therapists. Although the exact mechanism underlying its clinical effects is not known, therapeutic US has been shown to have a variety of effects at a cellular level, including angiogenesis, leukocyte adhesion, growth factor and collagen production, and increases in macrophage responsiveness, fibrinolysis, and nitric oxide levels. More recently, the therapeutic effects of US energy in the kilohertz range have been examined. It has been proposed that low frequency US in this range may improve wound healing via the production, vibration, and movement of micron-sized bubbles in the coupling medium and tissue.
The mechanical energy from US is typically transmitted to tissue through a coupling gel. Several high-intensity US devices with contact probes are currently available for wound debridement. A non-contact low-intensity US device has been developed that does not require use of a coupling gel or other direct contact. The MIST Therapy™ System (Celleration, Eden Prairie, MN) delivers a saline mist to the wound with low-frequency US (40 KHz); it includes a generator, a transducer, and a disposable applicator for discharge of prepackaged saline.
In 2005, the Celleration MIST therapy device received marketing clearance (K050129) through the U.S. Food and Drug Administration’s (FDA) 510(k) process, “to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.” Several wound drainage and wound vacuum systems were listed as predicate devices. In 2004, the FDA had reclassified these devices from class III to class II at the request of Celleration (K032378).
In 2007, the AR1000 Ultrasonic Wound Therapy System (Arobella Medical) received marketing clearance, listing the Celleration MIST system and several other ultrasonic wound debridement and hydrosurgery systems as predicate devices. The AR1000 system uses a combination of irrigation and US with a contact probe to debride and cleanse wounds. The indications are similar to that of the MIST system, listed as: “selective dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter.”
POLICY
Non-contact ultrasound treatment for wounds is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Currently available scientific evidence does not permit conclusions concerning the effect of this technology on health outcomes. Well-designed and blinded studies with additional subjects that include all relevant outcomes are needed to evaluate this treatment. Therefore, non-contact ultrasound treatment for wounds is considered investigational.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2010). Non-contact ultrasound treatment for wounds (2.01.79). Retrieved December 29, 2010 from BlueWeb. (7 articles and / or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/4/2011
MOST RECENT REVIEW DATE: 4/4/2011
ID_EBA
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