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|Medtronic Announces Global Launch of Titanium-Coated Peek Interbody Fusion Devices|
MEMPHIS, TENN., - October 20, 2014 - Medtronic, Inc. (NYSE: MDT) introduced its Pure Titanium Coating (PTC) platform of interbody fusion devices for the spine today at the 2014 Congress of Neurological Surgeons (CNS) Annual Meeting in Boston. The PTC platform includes four products: the CAPSTONE PTC(TM) Spinal System, CLYDESDALE PTC(TM) Spinal System, ANATOMIC PEEK PTC Cervical Fusion System and CORNERSTONE-SR® Ti- Coated Anatomical Cervical Cage.
These devices are used to treat patients experiencing pain caused by compression of the spinal cord or nerve roots by helping to restore normal disc height. Disc height restoration may reduce the pressure on the nerve roots and the spinal cord and help alleviate much of the patient's pain.
Medtronic's PTC devices represent an evolution in interbody fusion technology because they are constructed of a combination of the two materials most commonly used in interbody fusion procedures: titanium and polyetheretherketone (PEEK). Both materials have a long clinical history of being used in orthopaedic and other medical implants. Surgeons have historically preferred interbody spacers made of titanium because of their strength and long clinical history. However, over the last 10 years PEEK has largely replaced titanium as the material of choice because it has a modulus of elasticity that is similar to human cortical bone1 and it does not show up on X-rays2. This radiolucency enables the surgeon to more easily assess the surgical site over time after surgery.
With the application of a thin layer of textured pure titanium about 1/10th of a millimeter thick to the top and bottom of each PEEK implant, the PTC devices possess attributes of both PEEK and titanium. Specifically, as demonstrated in mechanical testing compared to PEEK alone, the pure titanium coating has a greater coefficient of friction.3 Additionally, this textured coating increases the surface area of the implant, which means there is more area for bone to come into contact with the surface of the implant.4 Yet, the titanium layer is thin enough that it does not change the radiolucency or mechanical properties of the underlying PEEK implant.
"Our PTC platform of interbody spacers is the result of our relentless effort to add value to our products and respond to surgeon needs by offering the advantages of combined materials in a single implant," said Doug King, president of the Spine business and senior vice president at Medtronic. "We will continue to leverage our innovation to produce more advanced and differentiated products for surgeons to use to treat their patients."
For Global Launch
For U.S. Launch Only
For Launch Outside the U.S. Only
Indications for these devices are as follows:
The CAPSTONE PTC(TM) Spinal System, the CLYDESDALE PTC(TM) Spinal System, CORNERSTONE-SR® Ti-Coated Cervical Fusion System, and the ANATOMIC PEEK PTC Cervical Fusion System incorporate the technology of Gary K. Michelson, M.D.
About Medtronic's Spinal Business
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1Mummaneni PV, Haid RW, Rodts GE. Lumbar interbody fusion: state-of-the-art technical advances. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. Journal of neurosurgery Spine 2004;1:24-30.
2Kurtz SM, Devine JN. PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomat 2007;28:4845-69.
3 Internal Medtronic Test Data
4 Medtronic Internal Test Data