An open letter to EMS Swiss DolorClast® users
May 19, 2010 - Dallas, Texas
Electro Medical Systems Corp. is pleased to clarify for its users, recent enforcement activity at the US Food and Drug Administration with regards to shockwave technology for pain relief.
Published peer reviewed, level 1, randomized controlled trials supporting the safety and efficacy of the EMS Swiss DolorClast® and FDA approval continue to validate the proprietary significance of the Swiss DolorClast® method.
EMS continues to stand by its belief that the Investigational Device Exemption (IDE) study is important for maintaining the public health, adhering to the scientific process, and abiding by U.S. Regulatory Law.
EMS thanks you for your continued support of our Swiss DolorClast® Radial Shock Wave Therapy® device, FDA approved (PMA P050004) for pain relief in treating Chronic Plantar Fasciitis after 6 months of conservative therapy in patients 18 years and older.
FDA considers a Class 1 submission as “lowest risk” devices that may bypass the lengthy and costly trials needed to enter the US marketplace. Examples of Class 1 medical devices are: tongue depressors, elastic bandages, reading glasses and forceps.
-Schmitz, De Pace, Urol Res, April 2009, 37:231–234
Validating the clinical claims of our radial shockwave technology platform is the responsibility of EMS. The U.S. FDA provides all medical device manufacturers the regulatory framework with which to do so.
EMS thanks you for your continued support of our Swiss DolorClast© Radial Shock Wave Therapy® device, FDA approved (PMA P050004) for pain relief in treating Chronic Plantar Fasciitis after 6 months of conservative therapy in patients 18 years and older.
2nd ATRAD WORLD CONGRESS – President John P. Furia M.D.
October 30th, 2010 – Berlin
ATRAD, the Association for Radial Pain Therapy (Art.60 ff of the Swiss Federal Legislation), is an international medical organization dealing with all issues related to Radial Shock Wave Therapy.
ATRAD promotes research and application of Radial Extracorporeal Shock Wave Therapy (ESWT) using the Swiss DolorClast® method and national and international dissemination of knowledge from science and practice in the interests of improved patient care.
For more information, please visit www.atrad-berlin2010.com
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For more information, please contact Jennifer Butler: firstname.lastname@example.org