Press Release

Medtronic Announces Launch of DIVERGENCE(TM) Stand Alone Interbody Cage

Medtronic, Inc.

DUBLIN - May 4, 2015 - Medtronic plc (NYSE: MDT), today announced the launch of the DIVERGENCE(TM) Stand Alone Interbody Cage. This device is now commercially available for the treatment of anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The announcement was made during the 83rd annual meeting of the American Association of Neurological Surgeons (AANS) in Washington, DC.

The DIVERGENCE(TM) Stand Alone Interbody Cage represents Medtronic's latest technology for anterior cervical discectomy with fusion (ACDF) procedures. It features an all-in-one fusion device with internal screw fixation, allowing for maximum distance from the adjacent level disc. Literature shows that maximizing that distance may lower the incidence of Adjacent Level Ossification Development (ALOD) or bone growth next to the treated leveli.  This device also incorporates divergent screw technique, which reduces retraction and incision.

"With this latest addition, the breadth of Medtronic's updated cervical portfolio allows surgeons to treat most anterior cervical pathologies they encounter in the operating room from complex to degenerative with a number of options from which to choose," said Doug King, president of the Spinal business and senior vice president of Medtronic. "This system represents Medtronic's commitment to responding to surgeon needs, and innovating in ways that improve patient treatment and care."

Additionally, the DIVERGENCE(TM) screws feature a cortical cancellous thread design to help maximize bone screw purchase and both straight and angled instrumentation.

"Divergence offers an elegant surgical solution for a variety of cases, even for patients whose anatomy is unfavorable for the use of standard plate and screws, said Dr. Jean-Pierre Mobasser of the Goodman Campbell Brain and Spine Institute in Indianapolis, IN.  The Divergence Stand Alone Interbody Cage's internal screw fixation and wide array of size options provide a versatile solution for surgeons.  Unique, divergently angled screws and angled instrumentation also help to minimize incision and exposure."

About the DIVERGENCE(TM) Anterior Cervical Fusion System
The DIVERGENCE(TM) Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCE(TM) stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCE(TM) stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Risks of the DIVERGENCE(TM) Anterior Cervical Fusion System include but are not limited to early or late loosening of any or all components and the development of new radiculopathy, myelopathy or pain, and/or tissue or nerve damage caused by improper positioning and placement of implants or instruments.

The DIVERGENCE(TM) Anterior Cervical Fusion System incorporates the technology of
Gary K. Michelson, MD.

About Medtronic Spinal
Medtronic's Spinal business, based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. Medtronic's Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art therapies for spinal, neurological, orthopaedic and oral maxillofacial conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies.  More information about Spinal's therapies can be found at the business unit's patient-education website, www.back.com.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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i Lee et al. Anterior cervical plating technique to prevent adjacent-level ossification development.
The Spine Journal 13 (2013) 823-829.


 

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