UPDATE: Integra Lifesciences Wins FDA 510(K) Clearance for C3-T3

Integra LifeSciences Holdings Corporation IART today announced the introduction of the Integra® Laminoplasty System, a comprehensive set of implants and instruments designed for use after open-door laminoplasty procedures in the cervical and thoracic spine (C3-T3). The system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and will be featured at the North American Spine Society (NASS) 28th annual meeting, October 9 – 12, 2013, in New Orleans, Louisiana. The Integra Laminoplasty System incorporates several plate and screw options, enabling surgeons to treat varying patient anatomies. The user-friendly system includes multiple plate insertion and drill guide options, and a new retentive screw driver, ensuring a seamless approach to laminoplasty procedures. "We're very pleased that we can now offer surgeons a comprehensive and easy-to-use treatment option for laminoplasty procedures," said Kirt Stephenson, President, U.S. Spine. "Our new Laminoplasty System should be a welcome addition to surgeons' repertoire of spinal therapies." Laminoplasty procedures treat spinal stenosis by relieving pressure on the spinal cord. The open-door laminoplasty procedure relieves pressure by first cutting the lamina on both sides of the affected vertebrae (a hinge on one side and a groove on the other), and See full press release