ROME & SAN JOSE, Calif.–(BUSINESS WIRE)–SpineAlign Medical, Inc. (formerly SpineWorks Medical, Inc.) announced today the presentations of Dr. Giovanni Carlo Anselmetti, MD of the Institute for Cancer Research and Treatment in Turin, Italy and his associate, Antonio Manca, MD. This clinical data, using the SpineAlign System, was presented at the recent American Society of Spine Radiology (ASSR)/European Society of Neuroradiology (ESNR) joint conference in Rome. The presentation entitled, “Vertebral augmentation performed by means of percutaneous nitinol prosthesis placement: results and follow up in 34 patients” was conducted under the direction of Dr. Anselmetti.
“The SpineAlign implant worked well at restoring the vertebral body, lifting the endplates and allowing height restoration to be maintained until bone cement was injected. It also allowed me to slowly inject the bone cement, significantly reducing the risk of extravasation associated with traditional vertebroplasty,” said Dr. Anselmetti. “In addition, the ability to collapse and reposition, or even retrieve the implant entirely, prior to cement delivery, gives the SpineAlign device greater utility in delivering optimal reconstruction, than some of the other devices that do not even allow for simple adjustments related to positioning.”
Summary of the Presentation Results:
•34 patients, age range was 57-88, with an average age of 78 years.
•There were no reported complications or adverse events.
•Back pain significantly improved by an average of a 7.4 point reduction in Visual Analog Scale, (0 to 10 scoring).
•Significant vertebral height gain was achieved (p<0.0001) with peak value at the midpoint in sagittal view (average of 4.5 ±3.7mm).
•The average Oswestry Disability Index score, an indication of quality-of-life, improved from 70.3% to 5.4% , an improvement of 64.9%.
•Two (2) vertebra plana (compression fractures >70%) were treated successfully.