Extracorporeal Shockwave Therapy: The Dornier Epos Ultra - Level One Evidence

September 15th, 2017

David Zuckerman DPM
Excellence Shockwave Therapy

It has been over 17 years since I first was introduced to the extracorporeal shockwave therapy (ESWT) for the treatment of plantar fasciosis and other forms of tendinopathy. Is ESWT still the best treatment for tendinopathy? Are there any new clinical studies about this treatment? Are there other products that FDA has approved? In fact, some devices on the today’s market are now being labeled as ESWT devices which aren’t even indicated for the treatment of foot and ankle diseases [4].

ESWT is a treatment involving shockwaves or high energy pulses created by an electromagnetic coil or a spark in water. These pulses are started externally to the body and transmitted via a special pad directly into the skin. This high energy treatment is used successfully all over the world in orthopedics, podiatry, physical therapy, urology and cardiology. Unfortunately, I have also observed the improper use of mislabeled ESWT equipment in podiatry and orthopedics over the years. Doctors and patients need to be educated in identifying proper ESWT equipment and accurate usage [4].

My primary goal is to educate podiatrists and orthopedists the importance of choosing an FDA approved, Class 3 device with Level One Evidence [5]. It may be unethical for a doctor to simply recommend one brand of device without controlled studies or approval by FDA. The FDA has a role to ensure both safety and efficacy in today’s consumer driven healthcare market. This includes control and supervision of medical devices as well as monitoring physician advertising. Evidence-based medicine is the key to our future as physicians and scientists. Our patients deserve this consideration. The 100s of studies over the years on ESWT speak for themselves.

The Dornier Epos Ultra device is based on sound science and received FDA clearance in 2002. The Dornier device is considered the gold standard among other ESWT devices in terms of positive long-term patient outcomes, as shown in several well-designed peer-reviewed studies in the U.S. over the past 15 years [1].

Dornier Medtech is the original company that pioneered and developed both kidney stone lithotripsy and orthopedic lithotripsy for the treatments of tendon conditions and plantar fasciosis. Researchers carried out a one-year study in Harvard Medical School, Emory Medical School, Henry Ford Hospital and Kennedy-Fowler Sport Clinic. This was multicenter double-blind randomized controlled trial [1]. Pain was assessed by using VAS and Roles Maundley scores. One hundred fifty four patients participated. The result showed that on average the pain level reduced by 92%. In addition, 94% of the patients reported that their symptoms improved significantly. Placebo controlled patients were treated and unblinded at the 12-week endpoint [1].

A follow up study known as the North American Confirmatory Study was conducted in 2003. It had the same outcomes. Initial FDA approval was also obtained from these studies. The most recent advertised “shockwave” devices, EPAT and Zimmer, are not currently FDA approved for orthopedic treatment for foot and ankle diseases. They are only simple massage devices [4].

In my experience, the Dornier Epos Ultra is proven to be more effective than other devices because it relies on ultrasound principles. The practicing physicians can actually observe the pathogenesis and focus on the degenerative areas along the tendon. Dosage of energy in the tissues is monitored and recorded in the chart. Clinical effectiveness depends on proper selection of patients as well as optimum dosage of the shockwaves by users.

Patients expect to have good long-term outcomes and long-term relief from pain. Wang showed that there was less than 10% re-occurrence of pain after receiving high energy ESWT treatments over a five-year period [6].

In conclusion, it has been shown and proven through peer-reviewed scientific publications that the Dornier Epos Ultra is an effective FDA-approved device. A full treatment only takes 30 minutes or less and it can be done in an outpatient setting. The Dornier device has been approved by FDA and has had a track record of over 17 years with Level One Evidence. I conclude that the Dornier Epos Ultra is the best device for treating patients with tendinopathy.

David Zuckerman DPM Excellence Shockwave Therapy

References

1. Theodore, G., et. al. (“Extracorporeal Shock Wave Therapy for the Treatment of Plantar Faciitis.” Foot & Ankle International , Volume 25, No. 5:290-297
2. Dornier Medical Systems, Inc. (2002). Dornier EposTM Ultra summary of safety and effectiveness, PMA #P000048. Provided by fax from Dornier on December 9, 2002
3. Kudo, Patricia, et al, “A Randomized , Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Plantar Fasciitis with an Extracorporeal Shockwave Therapy Device.
4. Public Health Service – Food and Drug Administration to the President of Storz Medical Ag, 2010, in Warning Letters. D-Actor® 50 and D-Actor® 200 devices. Last updated May 2010. http://www.fda.gov/cdrh/devadv....
5. American Academy of Orthopaedic Surgeons, 2008. Levels of evidence for primary research question.
   • Level I: Highest (blinded, randomized, placebo-controlled)
   • Level II: Non-randomized, placebo controlled
   • Level III: Non-randomized, case-cohort, prospective
   • Level IV: Retrospective
   • Level V: Expert Opinion
6. Wang, Chin Jeng, MD, et al. Long-Term Results of Extracorporeal Shockwave Treatment for Plantar Fasciitis. The American Journal of Sports Medicine. April 2006. 34: 592-596.

References of Interest

Blue Cross & Blue Shield Association. Technology Evaluation Center: Assessment Program Vol. 19, No. 18, March 2005. Extracorporeal Shock Wave Treatment for Chronic Plantar Fasciitis. Retrieved on 6/6/2007: http://blueweb.bcbs.com/global...