Orbasone Pain Relief System - P040039

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Orbasone Pain Relief System
Manufacturer: Orthometrix, Inc.
Address: 106 Corporate Park Drive, #106, White Plains, New York 10604
Approval Date: August 10, 2005
Approval Letter: http://www.fda.gov/cdrh/pdf4/P040039a.pdf

What is it?
The Orbasone Pain Relief System is a non-invasive, alternative to surgery that uses strong sound waves (extracorporeal shock wave energy) to relieve heel pain (proximal plantar faciitis).

How does it work?
The Orbasone Pain Relief System is an electro-hydraulic device, which uses the spark gap method to create a shock wave. With this technique, an electrode (spark plug) ignites an electrical charge within a water-contained, stainless steel, semi-ellipsoid chamber and contact membrane, evaporating a small portion of the water and creating a shock wave that reflects outward off the ellipsoid. The shock wave is generated within the reflector chamber and transmitted through the skin surface to the treatment site. Coupling solution is used on both the contact membrane and the patient¡¯s skin during treatment to enhance conductivity.

When is it used?
Plantar Fasciitis is an inflammation of the plantar fascia, the connective tissue that stretches from the base of the toes, across the arch of the foot and inserts into the heel bone. Proximal plantar fasciitis is heel pain in the area where the plantar fascia inserts into the heel bone.

The Orbasone Pain Relief System is used for the treatment of heel pain with or without heel spur in patients 18 years of age or older. The device is a non-invasive, alternative to surgery intended to apply extracorporeal shock wave energy to the heel tissue of patients who have had proximal plantar fasciitis for 6 months or more, and who have failed previous conservative therapies to relieve their heel pain.

What will it accomplish?
The Orbasone Pain Relief System is a non-invasive alternative to surgery. Potential adverse events of the Orbasone device include: bruising, mild edema, pain, swelling, and tingling.

When should it not be used?
The Orbasone Pain Relief System should not be used:

• Over or near bone growth centers until bone growth is complete
• When a malignancy is know to be present in or near the treatment area
• When the treatment site has open wounds, skin rashes, swollen, inflamed, or infected areas
• Over ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis may result
• In a patient who has a coagulation disorder or is taking anticoagulant medications, either for acute or chronic anticoagulant therapy
• In a patient who has an infection at the treatment site to avoid the risk of spreading infection
• In a patient who has a history of latex allergy or allergy to coupling solution

Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.fda.gov/cdrh/PDF4/p040039.html