This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Siemens SONOCUR® Basic System
Manufacturer: Siemens Medical Solutions, Inc.
Address: 186 Wood Avenue South, Iselin, NJ 08830
Approval Date: July 19, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p010039a.pdf
What is it? The SONOCUR® Basic System is a new treatment for pain due to tennis elbow. It uses a technology called extracorporeal shock wave therapy, in which low-energy pulses of sound (shock waves) are directed at the elbow to reduce pain
How does it work? The SONOCUR® Basic System is an outpatient treatment performed without anesthesia in a doctor’s office. Before treatment, the patient is positioned so that the elbow does not move. A technician covers the elbow with gel and then places the head of the device over the most painful part of the elbow. Once it is positioned correctly, the device administers a preset number of low-energy pulses or shock waves. The shock waves travel through a small water cushion and focus on the painful area. Some patients require more than one treatment with SONOCUR®.
When is it used? SONOCUR® can be used to treat patients with tennis elbow whose pain remained despite six months of standard treatment.
What will it accomplish? Treatment with the SONOCUR® Basic System can help reduce the pain from tennis elbow.
When should it not be used? The safety and effectiveness of the SONOCUR® Basic System has not been determined for the following groups:
- Pregnant women;
- Patients younger than 18 years of age;
- Patients with blood clotting diseases, infections, tumors, cervical compression, arthritis of the spine or arm, or nerve damage;
- Patients with cardiac pacemakers;
- Patients who had physical or occupational therapy within the past 4 weeks;
- who received a local steroid injection within the past 6 weeks;
- Patients with tennis elbow in both arms;
- Patients who had previous surgery for tennis elbow.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010039