Lanx’s Aspen System Achieves 94% Fusion Rate (Orthopedics This Week)
Lanx, Inc.’s Aspen MIS Fusion System has demonstrated a 94% fusion rate, according to new clinical data from a study announced by the company on September 17.
The study, presented by Amir Vokshoor, M.D., of the Institute of Neurosurgical Innovation, Marina del Rey, California, evaluated 85 consecutive patients who underwent lumbar fusion with the Aspen system. An independent radiologist, according to the company, used post-operative CT imaging to assess posterior fusion, as well as interbody fusion when applicable, and found it was successfully achieved in 94% of patients. Additionally, pain reduction was evaluated using Visual Analog Scale (VAS) values measured pre-operatively and post-operatively for up to two years, with findings demonstrating a clinically and statistically significant improvement from an average score of 6.5/10 pre-operatively to 2.9/10 within three months following surgery. This level of improvement was maintained throughout the follow-up period.
The data were presented at the Western Neurosurgical Society annual meeting held September 7-10 in Colorado Springs, Colorado.
Dan Gladney, the company’s CEO, said, “These data help substantiate the clinical equivalency of the Aspen system to traditional pedicle screws in promoting fusion, a finding that is widely supported by surgeon experience. 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.”
In response to a question about the fusion rate comparison to traditional pedicle screws, a company spokesperson told OTW that the study involved only Aspen device patients and looked at their outcomes, and the quote refers to the fact that, “this is as high as outcomes often reported with pedicle screws.” There will be data presented at the Congress of Neurological Surgeons next month that does specifically compare Aspen to pedicle screws.
The system is currently being used in a wide range of surgical applications including posterior lumbar fusions (PLF) and interbody fusions (PLIF, TLIF, ALIF and Lateral) for the treatment of degenerative disc disease, spondylolisthesis, spinal trauma or spinal tumor.