NEW YORK–(BUSINESS WIRE)–Centinel Spine, Inc. (Centinel), a leader in developing Integrated Interbody Fusion™ devices, announced today that it has received 510(K) clearance from the U.S. Food and Drug Administration to market its new STALIF MIDLINE™ system. The company anticipates that the system will become the next generation in anterior lumbar interbody fusion technology.
“We are very pleased to have received FDA clearance for this next generation lumbar device. The timing of the FDA clearance coincides with this year’s meetings of the North American Spine Society (NASS) and Congress of Neurological Surgeons (CNS) where we look forward to showcasing STALIF MIDLINE.”
Centinel will be initiating an Alpha launch of the MIDLINE™ system later this month with the participation of leading U.S. spine surgeons.
Centinel’s Chairman and Chief Executive Officer, John J. Viscogliosi, said, “We are very pleased to have received FDA clearance for this next generation lumbar device. The timing of the FDA clearance coincides with this year’s meetings of the North American Spine Society (NASS) and Congress of Neurological Surgeons (CNS) where we look forward to showcasing STALIF MIDLINE.”
An Effective Combination of New and Proven Technology
Developed around the proven technology behind Centinel’s highly successful STALIF TT™ and fast growing STALIF C™ systems, the STALIF MIDLINE Integrated Interbody Fusion™ system offers both clinically validated technology and new convenience features. These include Lag Effect Fixation™ consistent with the principles of segmental fixation and Wolff’s Law. Also engineered into STALIF MIDLINE is Lumen Locking™ – which guards against screw back-out.
To further mitigate the possibility of screw back-out, STALIF’s new ABO™ (Anti Back-Out) screw technology has been integrated into the MIDLINE system – offering added peace of mind for both patient and surgeon. The MIDLINE also offers surgeons the convenience of a full spectrum of implant sizes to accommodate a wide range of patient morphology as well as a new family of surgical tools engineered specifically for MIDLINE use.
Michael Will, Centinel’s President, noted, “Our goal in developing the MIDLINE device is to help surgeons achieve optimal spinal stabilization in the least invasive and most efficient manner. By providing the proven biomechanics of the original STALIF technology with the design enhancements surgeons have requested, we anticipate that the MIDLINE will exceed expectations.“
About Centinel Spine, Inc.
STALIF MIDLINE™ is the latest in a series of anterior fusion devices developed, marketed and sold by Centinel Spine, Inc. Founded in 2008, Centinel Spine, Inc. is an innovative spinal device company committed to the design and development of simple, biomechanically sound solutions for spinal stabilization and fusion. The company is recognized as a leader in the expanding Integrated Interbody Fusion spinal market segment.
STALIF™, STALIF TT™, STALIF MIDLINE™, Lag Effect Fixation™, ABO™ and Integrated Interbody Fusion™ are registered trademarks or trademarks of Centinel Spine, Inc. in the United States and/or other countries.
For more information on Centinel Spine:
www.centinelspine.com
