Miami, FL, USA (May 5, 2008)- Globus Medical, Inc., the largest privately held spinal implant manufacturer in the world and a recognized leader in motion preservation technology, today announced the completion of enrollment in its SECURE®-C Cervical Artificial Disc IDE study. The SECURE®-C device is designed to mimic the normal motion of the spine in order to alleviate pain and restore function as an alternative to fusion in the treatment of symptomatic cervical disc disease. A total of 380 patients have been enrolled in the trail.
“The SECURE®-C implant was designed specifically to mimic the physiologic behavior of the natural healthy spine,” said Dr. Joseph M. Marzluff M.D., a neurosurgeon in Charleston, SC, who has enrolled dozens of patients in the trial. “The device is a significant breakthrough in treating patients, offering distinct advantages over currently available devices and a simple surgical technique that is easier than traditional plate and screw insertion. We can clearly see the clinical advantages of restoring motion to the cervical spine with our patients, particularly with the device’s unique articulating surfaces and translation feature that helps them to regain previously limited motion.”
Kelly Baker, Ph.D., Director of Clinical Affair and Regulatory, adds, “Completion of enrollment in our first IDE is further validation of our unique product development and regulatory process and will set the stage for our extensive efforts in motion preservation. We are extremely grateful to our dedicated investigators and staff as their contributions have been critical to successful completion of enrollment. We look forward to continued patient follow-up, and PMA submission for ultimate market entry within the next two years.”
Globus plans to initiate two more US IDE clinical trials this year on motion preservation devices. Three of the company’s posterior motion preservation technologies (none of which are currently available in the United States): the TRIUMPH™ Posterolateral Disc, the TRANSITION™ Posterior Dynamic Stabilization System, and the FLEXUS™ Inspious Process Spacer System are among the numerous research posters and presentations concerning the Company’s products at this week’s Spine Arthroplasty Society (SAS) meeting in Miami, Florida.