Dornier MedTech responds to flawed Australian study involving extracorporeal shock wave therapy (ESWT) for the treatment of plantar fasciitis

ATLANTA, GA – SEPTEMBER 24, 2002 – As the inventor of both extracorporeal shock wave lithotripsy (ESWL) and extracorporeal shock wave therapy (ESWT), Dornier MedTech is compelled to respond to the recent Australian article published in the "Journal of the American Medical Association," which erroneously concluded that ESWT demonstrated no benefit for the treatment of plantar fasciitis.

To begin, it’s important to point out that the Australian article never underwent a thorough peer review process by U.S. medical experts in the field, specifically orthopedic surgeons or podiatrists who have conducted ESWT and have seen the therapeutic benefits firsthand.

When comparing the Australian study to the FDA clinical studies, the Australian study’s flaws are numerous. First, the Australian study actually treated the placebo group with shock wave therapy – just at lower energy levels and less number of shocks.

"Giving even a slight dose to the placebo group effectively treated everybody and confounded the results," said George Theodore, M.D., an orthopedic surgeon at Massachusetts General Hospital who served as a principal investigator in the FDA study. "I will certainly continue to use the treatment and am finding a 70 percent improvement rate at six months," he added.

The FDA study found good to excellent results for 60 percent of the patients at three months and over 90 percent of the patients at one year.

The Australian study included patients with only six weeks of heel pain – and no minimum baseline pain was required. The U.S. study required patients to have a minimum VAS pain score of 5 – and heel pain for at least six months with no response to at least three conservative therapy approaches.

"Those in the Australian study with pain for only six weeks would not have been approved for shock wave therapy because 90 percent of patients improve by six months," Dr. Theodore said. "ESWT in the United States is approved for the most severe, chronic cases."

The patients in the Australian study were given one low-energy treatment a week for three weeks. A single, stronger dose treatment, as approved in the U.S. using Dornier’s Epos Ultra, shows greater results.

The Epos Ultra is unique in its ability to deliver up to seven different energy levels, from low to high, unlike other devices on the market, which can deliver only a single low energy level or a single high energy dose. Practitioners using the Epos Ultra can customize treatment options for individual patients. Additionally, the Epos Ultra is the only device on the market with built-in ultrasound guidance, so the physician can closely monitor patient therapy before, during and after treatment.

"We were surprised and obviously disturbed that an Australian study of this caliber would be published here in the U.S," said Brian Walsh, general manager at Dornier MedTech America. "The article’s misleading conclusions will, in the short term, be a disservice to the medical community and especially to the patients it serves.

"Looking back 20 years, there were skeptics to using shock wave therapy for kidney stones. And we know today that shock wave therapy is the preferred, gold standard of treatment for urinary stones. In addition to the comprehensive FDA studies that found statistically significant improvements in patients undergoing ESWT for plantar fasciitis, there are many more peer-reviewed studies from around the world that illustrate great successes using ESWT for orthopedic indications," Walsh added.

Dornier MedTech is a privately held international company that manufactures, markets and services lithotripters, orthopedic shock wave devices, urotables and a variety of medical and aesthetic lasers. For more information, telephone Dornier MedTech America at 1-800-367-6437.