MEMPHIS, Tenn., July 18 /PRNewswire-FirstCall/ -- Smith & Nephew’s Orthopaedic Trauma & Clinical Therapies division today announced FDA approval for its EXOGEN 4000+(TM) Bone Healing System.
The EXOGEN 4000+ Bone Healing System is a low-intensity pulsed ultrasound device that is externally applied 20 minutes a day over the site of a broken bone. It is the only bone stimulator:
- using ultrasound technology approved to treat fractures that that have failed to heal; - approved to heal specific fresh fractures faster
The EXOGEN 4000+ is medically proven to promote the body’s natural healing process, speeding the repair of a broken bone. The system is also clinically proven to speed up the healing of certain new fractures by 38 percent and effectively healing 86 percent of hard-to-heal bone fractures.
The system will launch in domestic and International markets in the fall of 2006, and will replace the EXOGEN 2000+(TM).
“Receiving FDA approval for the EXOGEN 4000+ Bone Healing System is yet another win for surgeons and patients. While the accelerated healing potential and non-union treatment capabilities of the system continue to provide the same non-invasive alternative to surgery, the design upgrades make it easier to operate further optimizing patient care,” said Ken Reali, vice president and general manager, Orthopaedic Clinical Therapies.
The EXOGEN 4000+ Bone Healing System offers the same patented ultrasound signal and same great results, but is easier to use and more compact. This device comes complete with a larger screen for easier visibility, a simple one-button operation, and a much louder audio beep to signal operation.
“The EXOGEN Bone Healing System plays a critical role in my orthopedic practice. Use of the EXOGEN system has helped many of my patients heal tough fractures and get back to their activities faster. For patients who are not good candidates for surgery, due to medical conditions, the EXOGEN system has healed their difficult and slow-to-heal fractures without surgery,” said Skip Whitman, M.D., F.A.A.O.S., Tri-County Orthopedic & Sports Medicine, Elkin, N.C.
(TM) Trademark of Smith & Nephew
About Us
Smith & Nephew is a global medical technology business, specializing in Orthopaedic Trauma & Clinical Therapies, Orthopaedic Reconstruction, Endoscopy and Advanced Wound Management products. Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies. Smith & Nephew is dedicated to helping improve people’s lives. The company prides itself on the strength of its relationships with its surgeons and professional healthcare customers, with whom its name is synonymous with high standards of performance, innovation and trust. The company has more than 8,500 employees and operates in 33 countries around the world and generated sales of nearly $2.6 billion.
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Smith & Nephew Orthopaedic Trauma & Clinical Therapies
CONTACT: Media, Victor Rocha of Smith & Nephew, +1-901-399-6771, orvictor.rocha@smithnephew.com
Web site: http://www.smith-nephew.com//
