A Medical Device Daily
LDR Spine (Austin, Texas) reported that during a controlled launch, the first 15 patients were enrolled in a cervical artificial disc study, in locations throughout the U.S., using its second-generation Mobi-C cervical disc prosthesis. The investigational device exemption (IDE) study was approved by the FDA earlier this year for both one and two-level implantations (Medical Device Daily, Feb. 1, 2006).
Arnold Schwartz, MD, and Paul Alongi, MD, of Orthopedic Spine Care at Huntington Hospital (Long Island, New York), were the first in the U.S. to implant a Mobi-C.
The device is the first second-generation disc approved for an investigational research study for both single and two-level disc surgeries concurrently, LDR said. Dan Peterson, MD, and John Stokes, MD, with Austin Brain and Spine performed the study's first two-level surgery at Brackenridge Hospital (Austin, Texas).
“Many cervical discs currently in IDE studies in the U.S. have center keels requiring cutting a channel into the top and bottom vertebrae in the spine,” said Stokes. “The Mobi-C design does not require this and therefore can be used in two-level patients without the potential concern of fracturing the vertebrae.”
The Mobi-C is designed to provide contained mobility for better replication of anatomical movements, a more natural range of mobility that includes what the company banners as “six degrees of freedom,” and one-step implantation to potentially simplify the surgical technique. Lateral stops on the inferior plate control and limit the movement of the mobile insert and reduce the potential for insert migration.
The study, to enroll up to 600 patients, will follow patients for two years. It will include up to 20 medical centers throughout the U.S.
It is expected to have a 50/50 split between the one- and two-level fusion arms of the study, with the control arm to be an anterior cervical discectomy and fusion, the current standard of care for cervical disc repair.
The company said it expects to complete enrollment by the end of 2006.