New cervical spine disc replacements in development

The devices are intended to simplify implantation and reduce complications associated with other implants or surgical options.

Two medical device companies are advancing clinical development of two cervical spine total disc replacement devices.

On June 30, NuVasive Inc. filed with the FDA for an investigational device exemption (IDE) for its Cerpass TDR. Approval will allow it to begin a pivotal human clinical study on the safety and efficacy of the device in the United States, according to a press release.

The Cerpass TDR incorporates a ceramic-on-ceramic design, which developers believe will increase durability and help eliminate potential problems, including wear debris from bearing surfaces such as polyethylene. The device, designed for implantation using an anterior approach to the cervical spinal region, also has a self-centering feature to ensure proper placement, the company said in a release.

Preclinical tests showed the Cerpass TDR yielded comparable results to other artificial spinal discs currently in FDA trials, the company noted.

Globus Medical Inc. also has a new cervical TDR prosthesis in development. The company recently initiated a clinical trial to evaluate its Secure-C cervical artificial disc, which is also under an IDE.

According to the company, over 15 centers in the United States have agreed to participate in the trial. Additionally, Joseph M. Marzluff, MD, a neurosurgeon in Charleston, S.C., has successfully implanted the device in two patients, the company noted.

The Secure-C also incorporates a design intended to simplify insertion and reduce long-term disadvantages associated with cervical spinal fusion, such as increased risk of degenerative disease at adjacent levels, according to a Globus Medical press release.

For more information:
NuVasive Inc.; Web site: www.nuvasive.com.
Globus Medical Inc.; Web site: www.globusmedical.com.