The safety and performance of the Elaspine™ Implant System in the treatment of lower back
pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing
clinical study (PMCS). The study will be enrolled within Germany and Switzerland in 3-5
clinical centres, including in average 10 patients per centre. The study is conducted in
accordance with the Standard ISO 14155, where applicable on clinical investigation of medical
devices for human subjects and other legal requirements.