TranS1’s AxiaLIF 1L+ product line, an instrumentation and implant system for L5-S1 lumbar fusion, has received the US Food and Drug Administration 510(k) clearance.
TranS1, a provider of minimally invasive approaches to lumbar spine surgery, is a medical device company focused on designing, developing and marketing products to treat degenerative conditions of the spine affecting the lower lumbar region.
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.
TranS1 president and CEO Ken Reali said the new AxiaLIF 1L+ system further demonstrates TranS1’s commitment to continuously advance proprietary AxiaLIF core technology.
"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," Reali said.
TranS1 currently markets the AxiaLIF family of products for single and multilevel lumbar fusion and the Vectre and Avatar posterior fixation systems.