June 26, 2012
-- Clearance avails new treatment electrodes in noninvasive monopolar radiofrequency technology.
OAKLAND, California – Alpha Orthopaedics, Inc. is pleased to announce that its innovative AT2 System featuring RelēF Technology has received 510(k) clearance from the Food and Drug Administration for the addition of smaller size treatment electrodes, thereby adding these devices to the company’s commercial line in the U.S. The smaller size 0.25cm2 and 1.50cm2 treatment electrodes complement current product offering by providing physicians with the option of achieving full skin-electrode contact in small anatomic surfaces, where the size of the current 3.00 cm2 treatment electrode was an impediment for its use.
RelēF Technology delivers Radiofrequency energy while cooling non-targeted tissues by conduction. The clinical benefit of the technology resides in its ability to induce tissular changes that incite the body’s wound healing response. Alpha Orthopaedics’
RelēF Technology works in a totally non-invasive fashion, representing a significant advantage over alternative means of inducing a similar response, which usually requires the use of needles or surgical procedures.
Dr. Diana Villegas, Alpha Orthopaedics’
Chief Scientific Officer, commented: “We are very pleased with this development. The new electrodes allow for better skin contact when a smaller size electrode is needed to guarantee that the safety features of the electrode are activated in smaller, thinner, or bonier anatomical regions. This development adds to the safety and versatility of RelēF.”
About Alpha Orthopaedics
Alpha Orthopaedics, Inc. is a highly innovative U.S.-based medical device company that develops and manufactures noninvasive technologies for the treatment of musculoskeletal conditions. The company is in a pre-market mode for its RelēF Technology having completed numerous clinical evaluations and market tests in preparation for a full commercial launch. To learn more about our business and our products, please visit www.alphaorthopaedics.com and www.relef.info