Integra LifeScience Marks the First Implantation of its Laminoplasty System

Integra LifeSciences reported the first implantation of its Integra laminoplasty system in the United States. The system, which is used to treat patients with ossification of the posterior longitudinal ligament, cervical myelopathy and degenerative spinal canal stenosis, was implanted by Douglas Orndorff, M.D., spine surgeon at the Mercy Medical Center in Durango, Colo.

The system received 510(k) clearance from the U.S. Food and Drug Administration in October last year.

Laminoplasty is an orthopedic surgical procedure for treating spinal stenosis by relieving pressure on the spinal cord. The procedure involves cutting the lamina on both sides of the affected vertebrae (cutting through on one side and merely cutting a groove on the other) and then “swinging” the freed flap of bone open thus relieving the pressure on the spinal cord. The spinous process may be removed to allow the lamina bone flap to be swung open. The bone flap is then propped open using small wedges or pieces of bone such that the enlarged spinal canal will remain in place.

This technique contrasts with vertebral laminectomy in the amount of bone and muscle tissue that has to be removed, displaced, or dissected in the procedure.

“Integra’s laminoplasty system provides surgeons with a versatile solution for treatment of central canal stenosis,” said Orndorff. “The patient presented with progressive cervical myelopathy, had lordotic cervical alignment, and no neck pain. She was the ideal candidate for this laminoplasty procedure.”

According to Orndorff, the instrumentation was “easy to work” with and allowed for “predictable” placement of the plate and screws.

“The plate’s arched radius is ideal for spinal canal expansion, and the foot on the plate provided effective initial stability,” he added. “It is also possible to contour and trim the plate to accommodate variable patient anatomy.”

The system is designed for use after open-door laminoplasty procedures in the cervical and thoracic spine (C3-T3). The system encompasses a variety of robust, arched plate designs, self-drilling bone screws and multiple insertion options, offering surgeons choices when treating patients with central canal stenosis and
myelopathy.

“The Integra laminoplasty system complements and expands our posterior cervical portfolio and offers surgeons an anatomic solution for laminoplasty procedures. We look forward to continued success and growth in this market,” said Brian Larkin, president of Integra’s spine business.

The global laminoplasty market is estimated to reach approximately $70 million by 2015, according to the company.

Plainsboro, N.J.-based Integra LifeSciences manufactures technology for orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery.