New York, NY, June 16, 2015 – Centinel Spine®, Inc., (Centinel Spine) the pioneer of Stand-Alone, No-Profile®, Integrated Interbody™ fusion devices receive FDA clearance for its STALIF MIDLINE®, MIDLINE II™, MIDLINE II-Ti™ (Ti–ACTIVE™) devices for use with allogeneic bone graft in lumbar spinal fusion procedures.
All Centinel Spine’s Stand-Alone, No-Profile, Integrated Interbody systems are indicated for use with both autograft and/or allogeneic bone graft in lumbar and cervical spinal fusion procedures. Both STALIF C® and STALIF C-Ti™, used in cervical fusion (ACDF) procedures, received their allogeneic clearance in late 2014.
“Surgeons can feel confident that if they choose allogeneic tissue or autograft bone they are using all our Integrated Interbody devices on-label in either anterior cervical or anterior lumbar spinal fusion (ALIF) procedures,” said John J. Viscogliosi, Chairman & CEO, Centinel Spine.
This new indication was FDA cleared in addition to our current lumbar products’ existing clearance. Centinel Spine developed MIDLINE II to strike a balance between historical, clinical success and new surgeon-driven features and benefits to evolve to the next generation of Integrated Interbody devices.
Jon I. White, MD, Irvine Orthopaedic Associates, Irvine, CA agreed, “In my practice, I prefer to use MIDLINE II for my anterior spinal fusion procedures as it provides the best stability and offers many unique features. The new allogeneic indication gives me additional peace of mind that I am providing the best care for my patients. In my opinion, MIDLINE II is the safest and easiest product to use.”
MIDLINE II also provides the traditional STALIF® benefits of compressive fixation with the horizontal inclination of it lag screws. “My patients have great clinical outcomes and are pleased that their surgery can be performed standalone, from the front only” continued Dr. White.
“With another first-to-the-market innovation, Centinel Spine continues to raise the gold standard in Integrated Interbody technologies,” added Mr. Viscogliosi.
About Centinel Spine, Inc.
Centinel Spine, Inc. is a privately-held spinal device company leading the development and commercialization of the Stand-Alone, No-Profile, Integrated Interbody fusion technologies. For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.centinelspine.com.
The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generating superior clinical outcomes.
Centinel Spine derived its name from the “Sentinel Sign” – the radiographic confirmation of a successful fusion anterior to the interbody device.
For more information, please contact:
Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380
LBL 131 R02