Lanx has reported positive data from a clinical trial of its Aspen minimally invasive spinous fusion system.
The company said the ASPEN system is currently being used in various surgical applications including posterior lumbar fusions and interbody fusions for treating degenerative disc disease, spondylolisthesis, spinal trauma or spinal tumor.
The prospective study has demonstrated 85 consecutive patients who underwent lumbar fusion to assess the safety and efficacy of Aspen system.
To evaluate posterior fusion and interbody fusion, post-operative CT imaging was conducted by an independent radiologist, while to assess pain reduction, Visual Analog Scale (VAS) values were measured pre-operatively and post-operatively for up to 2 years.
The results showed statistically significant improvement in pain from an average score of 6.5/10 pre-operatively to 2.9/10 within three months following surgery as well as 94% fusion rate was observed.
Lanx chief executive officer Dan Gladney said the data help substantiate the clinical equivalency of the Aspen system to traditional pedicle screws in promoting fusion.
"The ASPEN device was developed to be a minimally invasive alternative to pedicle screws in the appropriate cases, allowing surgeons to best tailor fusion procedures to patients’ needs, and we are encouraged by continued research supporting the positive outcomes achieved with the system," Gladney added.