Alpha Orthopaedics' AT2 System Receives Market Clearance From the U.S. Food and Drug Administration
Clearance avails new noninvasive monopolar radiofrequency technology to patients in the U.S.
HAYWARD, Calif. (December 22, 2008) – Alpha Orthopaedics, Inc. is pleased to announce that its innovative AT2™ System has received 510(k) clearance from the FDA, thereby clearing the device for commercial distribution in the U.S. This announcement comes just five months after the device received its CE mark for distribution in several European countries, including Germany and Italy.
The AT2 System is unique in that it delivers thermal radiofrequency energy to targeted tissues in a noninvasive manner using a process known as electrocoagulation. A number of painful conditions involving injured tendons and ligaments (connective tissue), such as tendinosis and fasciosis, can be noninvasively treated via electrocoagulation provided by the AT2 System.
The clinical benefit of the technology resides in its ability to induce the body’s wound healing response. The Alpha Orthopaedics AT2 System works in a totally non-invasive fashion, whereas other radiofrequency generators utilized for this purpose require an open procedure.
About Alpha Orthopaedics
Alpha Orthopaedics, Inc. is a highly innovative U.S.-based medical device company that develops, manufactures and markets noninvasive technologies for the treatment of orthopaedic conditions. To learn more about our business and our products, please visit www.alphaorthopaedics.com