Integra Rolls Out New Implants at NASS

During the recent annual meeting of the North American Spine Society, Integra LifeSciences Holdings Corp. introduced two new products.

The new-product rollouts include the Integra Laminoplasty System and the Hollywood NanoMetalene Interbody Device (IBD),

The Integra Laminoplasty System is a set of implants and instruments designed for use after open-door laminoplasty procedures in the cervical and thoracic spine (C3-T3).

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.

The system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The system incorporates several plate and screw options, allowing surgeons to treat varying patient anatomies. The system also includes multiple plate insertion and drill guide options, and a new retentive screw driver.

“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 of Integra’s U.S. Spine unit. “Our new Laminoplasty System should be a welcome addition to surgeons’ repertoire of spinal therapies.”

Integra also recently received 510(k) clearance from the FDA for the Hollywood NanoMetalene IBD and expects to begin a controlled market release in the U.S. later this year.

The IBD primarily is used in transforaminal lumbar interbody fusion, a surgical procedure designed to help alleviate pain and nerve compression by fusing and stabilizing adjacent vertebrae in the lower back.

IBDs are designed to help provide stability for spinal fusion after a diseased disc is surgically removed. They are small, hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height, and are intended to allow fusion between vertebral bodies. The graft window in the device is packed with bone, creating an environment in which the vertebral bodies can fuse together.

The Hollywood NanoMetalene IBD is composed of PEEK-Optima polymer, which has undergone a proprietary high-energy, low temperature surface process that creates a titanium coating around the entire implant, including the graft window in the middle of the IBD. This process provides the surface benefits of titanium without compromising the mechanical and imaging benefits of PEEK-Optima. The ultra-thin NanoMetalene coating does not impair postoperative imaging, allowing surgeons to view the operative area and determine the extent of fusion of the vertebral bodies.

“We’re very excited to introduce our first-ever spinal implant incorporating NanoMetalene technology,” said Stephenson. “Surgeons prefer the surface characteristics of titanium and the mechanical properties and radiolucency of PEEK-Optima, and the Hollywood NanoMetalene IBD offers a treatment option that incorporates both benefits into one device.”

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