Totalis® Direct Decompression System
The Totalis Direct Decompression System is a set of specialized instruments designed to safely perform minimally invasive direct decompressions of the lumbar spine. The system utilizes Vertiflex’s proprietary interspinous access platform and includes both reusable and disposable instruments to remove bone and soft tissue.
Totalis Direct Decompression System is CE marked and was 510k cleared for U.S. distribution by the FDA in November 2012.
Totalis® STEPS Trial
Right now, spine specialists throughout the U.S. are conducting a clinical trial of the Totalis® System – a minimally invasive alternative to traditional spine surgery that does not require general anesthesia and allows most patients to return home the same day. Enrollment in the trial is complete and results are expected in late 2016.