Zimmer receives clearance for pediatric use of Universal Clamp Spinal Fixation System

Sep 14 2011

Zimmer Holdings, Inc. (NYSE: ZMH; SIX: ZMH) announced today that it has received an additional clearance for its proprietary Universal Clamp Spinal Fixation System.  A first for the United States, the system is now indicated for treatment of idiopathic and neuromuscular scoliosis in patients eight years of age or older.  The Universal Clamp Spinal Fixation System is used in conjunction with spinal fusion surgeries.

Scoliosis is a debilitating condition characterized by spine curvature and back pain. In the United States, scoliosis affects approximately two to three percent of the population with more than 27,000 cases a year determined to be serious enough to require surgery.  Scoliosis is commonly diagnosed in childhood and early adolescence, with between three and five of every 1,000 children developing spinal curves that are considered large enough for treatment.  The most common surgical intervention performed to correct severe scoliosis is spinal fusion.  

Zimmer's Universal Clamp System was designed for use in conjunction with spinal deformity procedures.  Introduced in Europe in 2006 and in the United States in 2008, the Universal Clamp Implant offers a pedicle-sparing approach for malformed or small thoracic pedicles while still providing similar stability to pedicle screw constructs. The Universal Clamp band spreads contact forces over a greater surface area, thereby reducing the risk of pulling through the lamina compared to wires and hooks.  The system's reduction instrumentation allows surgeons to sequentially reduce deformity and spread the reduction forces over multiple levels.

"Scoliosis affects a significant number of young patients in the United States each year," said Steve Healy, President of Zimmer Spine.  "We are excited to make the Universal Clamp System available as an advanced solution for surgeons treating young patients."

Since its introduction, the Universal Clamp System has been successfully used in more than 24,000 procedures worldwide.  Following the latest clearance, Zimmer can now provide training and education for surgeons to treat child and adolescent patients in the United States with the technology.