Integra LifeSciences Receives FDA Clearance for Integra(R) Laminoplasty System
PLAINSBORO, N.J., Oct. 10, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: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 then prying the released segment of lamina open. A laminoplasty plate is attached to the lamina, to help retain the open position while it heals. The plate is also used to hold bone graft material in place and prevent it from expulsion and impinging on the spinal cord.
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. For more information, please visit www.integralife.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading "Risk Factors" included in Item IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2012 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
CONTACT: Integra LifeSciences Holdings Corporation
Gianna Sabella
Director, Corporate Communications
(609) 936-2389
gianna.sabella@integralife.com