Globus Medical (NYSE:GMED) won pre-market approval from the FDA for its Secure-C artificial cervical disc.
The Secure-C device is designed to restore normal movement to the neck in patients with disc problems that produce neck and arm pain. It consists of 2 cobalt-chrome endplates and a central polyethylene core that mimics the function of a healthy spinal disc.
An investigational device exemption study of the device involving 380 patients with intractable symptomatic cervical disc disease compared using the Secure-C device with standard anterior cervical discectomy and fusion. The 2-year study showed that 90.1% of patients who received the Secure-C device experienced at least 25% reduction in pain and disability according to the Neck Disability Index, required no further surgery and had no device-related complications. That compares with 71.1% of patients in the control arm.
The study also showed that 83.8% of the Secure-C cohort showed 15% improvement in NDI scores, maintained or improved neurologic status, no further surgeries, no device-related adverse events and no change in treatment after 2 years; in the control arm, 73.2% of patients achieved these additional success criteria, according to a press release.
“We are thrilled not only to receive our first PMA approval but to bring this excellent technology to the marketplace. The outstanding clinical performance of Secure-C has made this PMA well worth the effort and we hope it will be a great benefit to patients,” Kelly Baker, regulatory & clinical affairs vice president for Globus, said in prepared remarks.
The news sent GMED shares up as much as 18.3% last week to a 52-week high of $19.93, but prices have since come down to near pre-PMA levels. Globus shares were trading at $16.82 today as of about noon, just under its $16.85 close Sept. 27.
