Pioneer Surgical Technology, a USA-based manufacturer of implantable devices for orthopaedics and cardiothoracics, has announced that surgeons have carried out 2,000 successful implants of its NuNec PEEK cervical disc arthroplasty device in Europe, the Middle East and Africa (EMEA). NuNec is the first PEEK cervical disc replacement (CDR) launched in Europe. The first NuNec implantation in the EMEA market occurred in Germany in November 2008. The PEEK is Optima, supplied by UK-based PEEK manufacturer Invibio.
NuNec is indicated for skeletally mature patients with cervical degenerative disc disease (DDD) for reconstruction of discs from cervival vertebrae C3 to C7. DDD is defined as intractable radiculopathy and/or myelopathy with at least one of the following conditions confirmed via radiographic studies (for example CT, MRI or x-ray): herniated nucleus pulposus (slipped disc), spondylosis (osteoarthritis—defined by the presence of osteophytes), and/or the loss of disc height.
At its core, the NuNec device features a PEEK ball and socket articulation. The PEEK on PEEK design results in improved radiolucency and lower wear rates when compared to metal implants. The device utilises a unique CAM interference screw locking mechanism to provide immediate and primary fixation and the endplates are coated with hydroxyapatite.
"The NuNec disc provides the perfect combination of new materials and biomechanics versatility, allowing great MRI post-operative imaging and excellent multi-level clinical results," says Tai Friesem, MD, clinical lead of the spinal nit at the University Hospital of North Tees, Stockton-on-Tees, United Kingdom.
“The unique technology of NuNec confirms Pioneer’s commitment to developing quality solutions for healthcare practitioners and their patients,” says James St John, executive vice president of Global Distributed Spine. “This milestone is a huge success for our organisation and we plan to continue this success with ongoing expansion into new markets.”