FDAnews
www.fdanews.com/articles/75428-fda-approves-orthometrix-s-orbasone-eswt-system

FDA APPROVES ORTHOMETRIX'S ORBASONE ESWT SYSTEM

August 16, 2005

Orthometrix said its new Orbasone Pain Relief System has received market approval from the FDA for the treatment of chronic plantar fasciitis (foot pain).

The system, available to U.S. podiatrists, orthopedic surgeons and professional sport team physicians, uses high-energy shock waves to relieve chronic heel pain. The shock waves are created by a spark plug enclosed in a soft dome filled with water. The membrane-covered dome is placed against the heel so that the shock waves pass through the membrane to the heel. The extracorporeal shockwave therapy (ESWT) typically takes about 30 to 40 minutes and is delivered to patients under the supervision and care of a physician such as an orthopedic surgeon or a podiatrist.

The product is already used in several countries in Europe and Asia by podiatrists and orthopedic surgeons, and was approved for sale in Canada earlier this year.