Healthcare Industry News: RT Technology
News Release - August 21, 2007
DJO Incorporated Receives FDA Market Approval for Enhanced Patient Features for Its Line of OL1000 and SpinaLogic(R) Bone Growth Stimulation ProductsSAN DIEGO--(HSMN NewsFeed)--DJO Incorporated (NYSE:DJO ), a global provider of products and services that promote musculoskeletal and vascular health, today announced that it has received FDA approval for a supplement to the Company's existing Pre-Market Approval (PMA). The PMA supplement covers several new product features that are built into the control modules for its Combined Magnetic Field (CMF) OL1000 and SpinaLogic® bone growth stimulation product lines. The new product features enhance patients' ease of use.
The CMF OL1000 and SpinaLogic® devices are the only bone growth stimulation devices utilizing the unique and patented CMF technology. CMF is the only waveform clinically proven to stimulate bone growth from a simple 30 minute per day treatment with FDA-indicated use in both long bone and primary lumbar Spine applications. The new CMF OL1000 and SpinaLogic devices will continue to offer the same patient-friendly, single button, 30 minute treatment program to encourage patient compliance but are now even easier to use with an ergonomically designed control box, a louder audible beep signaling operation and enlarged LCD icon graphics that have more than doubled in size for better visibility.
Commenting on the FDA approval, Les Cross, DJO President and CEO, said, "As a market leader in bone growth stimulation, DJO will continue to innovate to provide doctors and their patients with efficacious and easy-to-use products through state-of-the-aRT Technology and user friendly features."
The new CMF OL1000 and SpinaLogic bone growth stimulation devices will launch in both domestic and international markets September 2007 and will replace the existing device configurations.
The CMF OL1000 and OL1000SC devices are indicated for non-invasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when a fracture site shows no visibly progressive signs of healing. The CMF SpinaLogic device is indicated as an adjunct electromagnetic treatment to primary lumbar spinal fusion for one or two levels. Visit www.cmfexperience.com for further information and full prescribing information.
About DJO Incorporated
DJO Incorporated is a global provider of solutions for musculoskeletal and vascular health, specializing in rehabilitation and regeneration products for the non-operative orthopedic, spine and vascular markets. Marketed under the Aircast®, DonJoy® and ProCare® brands, the Company's broad range of over 700 rehabilitation products, including rigid knee braces, soft goods and pain management products, are used in the prevention of injury, in the treatment of chronic conditions and for recovery after surgery or injury. The Company's regeneration products consist of bone growth stimulation devices that are used to treat nonunion fractures and as an adjunct therapy after spinal fusion surgery. The Company's vascular systems products help prevent deep vein thrombosis and pulmonary embolism that can occur after orthopedic and other surgeries. Together, these products provide solutions throughout the patient's continuum of care. The Company sells its products in the United States and in more than 70 other countries through networks of agents, distributors and its own direct sales force. Customers include orthopedic, podiatric and spine surgeons, orthotic and prosthetic centers, third-party distributors, hospitals, surgery centers, physical therapists, athletic trainers, other healthcare professionals and individual and team athletes. For additional information on the Company, please visit www.djortho.com.
Source: DJO Inc
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