TranS1 Announces AxiaLIF 1L+ 510(k) FDA Clearance
Published: Mar 24, 2011
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."
About TranS1 Inc.
TranS1 is a medical device company focused on designing, developing and marketing products that implement its proprietary approach to treat degenerative conditions of the spine affecting the lower lumbar region. TranS1 currently markets the AxiaLIF family of products for single and multilevel lumbar fusion and the Vectre and Avatar posterior fixation systems. TranS1 was founded in May 2000 and is headquartered in Wilmington, North Carolina. For more information, visit www.trans1.com.
TranS1 Inc. Investors: Joe Slattery, Chief Financial Officer 910-332-1700 Westwicke Partners Mark Klausner 443-213-0501 firstname.lastname@example.org