Spinal Stabilization Technologies (SST) has announced that it has earned the CE Mark and the FDA’s breakthrough designation for its PerQdisc™ Nucleus Replacement System for degenerative disc disease (DDD).
The PerQdisc device replaces the nucleus pulposus of the intervertebral disc in the L1 – S1 spinal region in patients with single-level discogenic pain. The patient may have single or multi-level DDD but the discogenic pain must be limited to a single level. Spinal Stabilization Technologies say that PerQdisc is the only commercially available lumbar nucleus replacement system in the world.
Mark Novotny, SST CEO, said: “Our technology, combined with new surgical and imaging techniques, allowed SST to solve the complex challenge of lumbar spine nucleus replacement.”
The novel procedure is a minimally invasive surgery compared to spinal fusion or total disc replacement and is done with a small incision that aims to minimise the risk of blood loss and result in a custom implant that fills the patient’s disc space. Patients are usually in the hospital overnight and can go home the following day. ”
The PerQdisc device and the surgical procedure are not yet FDA approved. “SST is working with the FDA to develop a comprehensive clinical trial program,” adds Novotny. “As part of that process, the FDA recently designated the PerQdisc as ‘breakthrough technology.’ In the meantime, with the CE Mark approval, SST has plans to launch sales of its device in Europe, the Middle East, and Asia including China.”