U.S. Food and Drug Administration Approves the Medispec Orthospec ESWT Device -- MEDICA - World Forum for Medicine


Medispec Ltd.

U.S. Food and Drug Administration Approves the Medispec Orthospec ESWT Device

Medispec's Orthospec

Germantown, MD, April 1, 2005: Medispec, Ltd. today announced the FDA approval of its Orthospec Extracorporeal Shock Wave Therapy System.. The Medispec Orthospec uses Electrohydraulic spark gap technology to treat chronic heel pain caused by proximal plantar fasciitis.

“The FDA approval of the Orthospec ESWT System is yet another stride Medispec has taken in the effort to make the most efficient and minimally-invasive medical treatments available to patients everywhere,” said Anil Dhingra, Vice President and COO of Medispec, Ltd.

The Orthospec (ESWT) is a non-invasive therapy for the treatment of heel pain. It employs shockwave technology similar to that used in urological lithotripsy devices to break kidney stones. Extracorporeal shock wave therapy can be used to treat patients who have suffered from chronic heel pain for at least six months and who have been unresponsive to conservative treatments.

The Orthospec has been proven to be safe and effective with its high-energy source and the largest (patented) therapy zone in the industry. Additionally, there is no anesthesia or imaging required during patient treatment. Patients will benefit from the shorter recovery time, compared to other treatments or surgical methods.

“This ESWT system offers the perfect combination of clinical performance and flexibility. It was advantageous for us to participate in the Orthospec clinical investigation. The patients of my podiatric practice showed great improvement in heel pain after being treated with this device,” said Dr. Amir Assili of Gaithersburg, MD.