Low Back Pain is a major social and economic problem affecting 80% of the total European population at some point of their life. It is estimated that Low Back Pain leads to direct and indirect costs reaching almost 0.1% of the EU’s Gross Domestic Product.
Lumbar Disc Herniation is one of the recurrent causes of Low Back Pain. The lumbar disc is made of two structures: a gel-like core (Nucleus Pulposus) and a ring of collagen fibres (Annulus Fibrosus) surrounding it. Lumbar discs act as shock absorbers for the spine. Disc herniation occurs when the annulus fibres break and the nucleus pulposus bursts out of the disc, thus pressing the nerves and tissues behind it causing back pain.
The gold standard treatment for disc herniation is Discectomy: eliminating the herniated nucleus pulposus through an incision in the annulus. Discectomy is often performed with minimally invasive surgery, which is when the whole procedure is done through a small incision in the skin.
The main drawback of the discectomy procedure is that the hole created in the wall of the annulus fibrosus is left open, thus there is a risk of re-herniation through this hole. Indeed, one year after the surgery, an average of 10% of patients are re-operated due to re-herniation. This entails an important socioeconomic burden: patients suffer the consequences of a complex and risky second surgery, long-term relapse of back pain and reduced quality of life, while insurance companies and Public Administrations have to assume the costs associated to reinterventions and recurrent sick leaves.
The objective of the ACE project is to broaden NEOS’ product portfolio by launching its first Spinal Product, an Annulus Closure Device. The ACE product will cover the unmet clinical need of managing disc re-herniation, by combining the latest advances in materials and manufacturing technologies into a mechanical solution that provides a permanent, strong and flexible barrier against re-herniation
