TranS1 Jumps 38%+ On Positive FDA Announcement (TSON)

TranS1

, a pioneer in minimally invasive approaches to lumbar spine surgery, today announced the 510(k) clearance of the AxiaLIF(R) 1L+ product line, an instrumentation and implant system for L5-S1 lumbar fusion. The AxiaLIF 1L+ system represents the next generation of the original AxiaLIF 1L system first launched in 2005 that has a clinical history of over 10,000 implants. TranS1 will commence a limited market release immediately with the new implant and instrumentation and anticipates full commercial release in the second half of 2011. "Our new AxiaLIF 1L+ system further demonstrates TranS1's commitment to continuously advance our proprietary AxiaLIF core technology. The 1L+ system builds upon our successful 2L+ system launched last year," stated Ken Reali, TranS1's President and CEO. "The modular approach of the 1L+, coupled with the tapered tip design, allows for more precise distraction capabilities and improvement in pull out strength. Further, through our minimally invasive pre-sacral access, the 1L+ implant provides a biomechanically stable implant at the base of the spine." "I am particularly excited by the availability of the 1L+ implant," commented Dr. James Billys from the Florida Orthopedic Institute. "The 1L+ represents a real advancement in the AxiaLIF technology that will allow me to manually distract the L5-S1 disc space providing even greater control of the procedure and ultimately a strong fusion outcome."