Siemens Medical Systems announced today that it has received the FDA's conditional approval for the continued clinical testing of its Sonocur sound-wave therapy device. The decision allows Iselin, NJ-based Siemens to continue clinical testing of the device, which is currently marketed in Europe and Canada. Sonocur is used to treat chronic orthopedic pain disorders such as lateral epicondylitis, commonly known as chronic tennis elbow.
Preliminary data suggest that Sonocur may be a viable alternative for patients who are non-responsive to other therapies, according to Gunther vom Dorp, Siemens product manager for extracorporal shockwave therapy. He said the device could significantly improve the quality of life for patients who must now limit daily activities or consider surgery.
Clinical testing of the device will continue at four study sites in Georgia, North Carolina, Pennsylvania, and Virginia, the company said.
By AuntMinnie.com staff writers
April 26, 2000