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.3Additionally, 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
The CAPSTONE PTC™ Spinal System and the CLYDESDALE PTC™ Spinal System received U.S. Food and Drug Administration (FDA) 510(k) clearance in March and launched in the U.S. in August. CE Mark (Conformité Européenne) was also received for both systems in July.
The CAPSTONE PTC™ Spinal System launched in Western Europe in September.
The CAPSTONE PTC™ Spinal System is expected to launch in Japan in November 2015 and CLYDESDALE PTC™ Spinal System is expected to launch in Japan in January 2016.
For U.S. Launch Only
The ANATOMIC PEEK PTC Cervical Fusion System has received FDA 510(k) clearance and launched in the U.S. in September.
For Launch Outside the U.S. Only
CORNERSTONE-SR® Ti- Coated Anatomical Cervical Cagehas received a CE Mark (Conformité Européenne) and launched in Western Europe in July. This system is not for use in the United States or its territories.
Indications for these devices are as follows:
CAPSTONE PTC™ Spinal System and CLYDESDALE PTC™ Spinal System are indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1, for interbody fusions in the lower back or lumbar spine. These devices are intended to be used with supplemental fixation.
CORNERSTONE-SR® Ti- Coated Cervical Fusion System is indicated for:
degenerative discopathy and instability
primary surgery for certain progressive degenerative discopathies or extensive anterior decompression
revision surgery for failed disc operation, stenosis, and/or post-operative instability
pseudarthrosis or failed arthrodesis
The ANATOMIC PEEK PTC Cervical Fusion System is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The ANATOMIC PEEK PTC device is to be used with supplemental fixation and autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The CAPSTONE PTC™ Spinal System, the CLYDESDALE PTC™ 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.