Medtronic plc has announced the U.S. FDA approval of the Prestige LP™ Cervical Disc for the treatment of cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the C3-C7 segments of the neck.
Background
Unlike a fusion surgery that does not preserve motion, Medtronic’s Prestige LP Disc is designed to allow motion in the neck at the operated levels. The device is Medtronic’s third clinically-proven artificial cervical disc and its first to be determined safe and effective for both one- and two-level procedures. Additionally, it is the first artificial disc on the U.S. market to be proven statistically superior in overall success for both one- and two-level procedures.
The low profile Prestige LP Disc has a ball-and-trough design and moves in a range of motions, including bending, rotation, and translation. The disc is made of titanium ceramic composite which provides improved wear resistance in combination with the mechanical, biocompatible, and imaging properties of the base titanium alloy. The device is MRI conditional at 1.5 and 3.0 Tesla and is now available in a smaller 5mm height.
The Prestige LP Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The Prestige LP Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of non-operative treatment or have had the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management prior to implantation of the Prestige LP Disc.
Physician comments
“For my active patients with cervical disc disease at two adjacent levels, I want to preserve motion in their necks,” said Dr. Jeff McConnell, a clinical trial investigator and orthopedic surgeon at Lehigh Valley Hospital in Allentown, Pa. “I choose to use the Prestige LP Disc at two levels because it provides superior clinical outcomes at 24 months and the titanium ceramic composite material allows post-op assessment and visualization by MRI.”
Company comments
“Medtronic is committed to elevating spine care by combining innovative new technologies with clinical evidence,” said Doug King, senior vice president and president of Medtronic’s Spine division, which is part of the Restorative Therapies Group at Medtronic. “The Prestige LP Disc is a superior alternative to ACDF and an important motion-preserving option for physicians treating certain patients suffering from two-level cervical disc disease.”
Source: Medtronic plc
published: July 19, 2016 in: Approval/Clearance, Medtronic, Spine