A Medical Device Daily

Med-tech giant Medtronic (Minneapolis) is reporting launch of its Peek Prevail Cervical Interbody Device, a product that is poised to treat patients who suffer from a degenerative condition that affects the neck (cervical spine). The device is an implant that is designed to provide stability during spinal fusion, a process that involves joining two bones together, such as adjacent vertebrae.

The device enters into a market where there are more than 200,000 cervical fusion procedures performed each year to relieve compression on the spinal cord or nerve roots.

The company says that the Peek Prevail Cervical Interbody Device is indicated for use in patients with cervical disc disease from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy (radiating pain) and/or myelopathy (weakness) with herniated disc and/or osteophyte formation on posterior vertebral end plates producing symptomatic nerve root and/or spinal cord compression.

The Peek Prevail Device is to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.

"The specific advantages of the Peek Prevail Cervical Interbody Device over other techniques – such as zero profile and device design – makes this an exciting option for today's spinal surgeon," said Richard Hynes, MD, president/medical director of the B.A.C.K. Center (Melbourne, Florida), in a company statement.

Typically surgeons can use bone graft to restore a patient's disc height and have traditionally covered the graft with a metal plate anchored to the spine with four screws to provide stability and prevent the bone graft from moving. The zero-profile Peek Prevail Device eliminates the need for a plate and attaches to the spine using only two screws.

Biomechanical data suggest that the Peek Prevail Device, with two integrated bone screws, provides construct rigidity similar to that obtained by the traditional fixation techniques of a threaded cage or plating.

Made of polyetheretherketone (PEEK), the new implant is invisible on X-rays, which allows the surgeon to view the spinal fusion during a follow-up visit. Featuring an "I-beam" shape with a two-screw configuration, the device incorporates a Nitinol wire locking mechanism to keep the screws securely in place.

In other company news, Medtronic reported the launch of the Vertex Select Reconstruction System Occipitocervical Module.

When a patient has a serious spinal condition that requires the base of the skull (occiput) to be fused, or joined, to the neck (cervical-upper thoracic spine), this complex procedure must be performed from the back of the spine, also known as a posterior approach. The Vertex Select Occipitocervical Module contains implants and an instrument set necessary for performing this surgical procedure.

Conditions of the spine, such as degenerative disease, can lead to instability and pain for patients. To treat the instability, surgeons perform a spinal fusion, which involves joining two bones together, such as the occiput and vertebrae.

Nearly 40,000 posterior cervical fusions are performed each year, of which nearly 10% involve occipitocervical fusions.

Used with the existing Vertex Reconstruction System, the Vertex Select Occipitocervical Module offers adjustability through multiple plate designs, rods, screws, and hooks that gives surgeons more options during surgery, enabling them to tailor the procedure to each patient's needs. Additional enhancements to the Vertex Select Reconstruction System will be released in the near future to further expand the system.

The flexibility of the Vertex Select Reconstruction System helps overcome challenges of occipitocervical fusion," said Vincent Traynelis, MD, neurosurgeon at Rush University Medical Center (Chicago). "The multiple fixation options provided by the Occipitocervical Module allow me to adapt to my patients' anatomy and adjust my constructs as needed."

Medtronic's Spinal and Biologics business, based in Memphis, develops products and technologies for neurological, orthopedic and spinal conditions.