Medtronic Announces FDA Approval of Infuse® Bone Graft for Three New Spine Surgery Indications

December 11, 2015 – Medtronic plc (NYSE: MDT) today announced U.S. Food
and Drug Administration
(FDA) approval of additional spine surgery indications
for Infuse® Bone Graft. Upon receiving final labeling approval from the FDA, the
company expects to begin marketing these expanded indications in early calendar
year 2016. With this expanded approval, Medtronic will be able to market Infuse
Bone Graft for use with certain spine implants made of polyetheretherketone
(PEEK) in oblique lateral interbody fusion (OLIF) and anterior lumbar interbody
fusion (ALIF) procedures.

The new indications for Infuse Bone Graft are:

* Use in OLIF51(TM) Procedures with certain sizes of the PEEK Perimeter®
Implant at a single level from L5-S1.
* Use in OLIF25(TM) Procedures with certain sizes of the PEEK Clydesdale®
Implant at a single level from L2-L5.
* Use in ALIF procedures with certain sizes of the PEEK Perimeter Implant at a
single level from L2-S1.

“For my anterior and anterolateral lumbar spine fusion cases, the use of Infuse
Bone Graft allows me to reliably obtain a solid arthrodesis without having to
harvest bone from the patient’s own hip which generally requires a second
incision, results in significant pain, and increases the risk of complications
such as bleeding or infection,” said Peter Whang, MD, FACS, an Associate
Professor in the Department of Orthopaedics at the Yale School of Medicine in
New Haven, CT.  “In particular, I believe that the proven osteoinductive
properties of Infuse Bone Graft are particularly beneficial when used in
conjunction with PEEK interbody spacers and the less invasive OLIF technique,
which circumvents the psoas muscle and minimizes disruption of the surrounding
soft tissues and neural structures.”

Infuse Bone Graft is used with certain Medtronic interbody fusion devices to
treat lumbar degenerative disc disease.  This condition can cause back and/or
leg pain, as well as functional problems, such as tingling or numbness in the
legs or buttocks or difficulty walking.

“With these expanded indications, we can bring the benefits of this important
technology to more patients to help ensure they achieve a solid fusion and the
best potential for a positive clinical outcome,” said Doug King, senior vice
president and president of Medtronic’s Spinal business, which is part of the
Restorative Therapies Group at Medtronic.  “We believe in the safety and
effectiveness of Infuse Bone Graft and reiterate our continued commitment to the

Infuse Bone Graft is FDA-approved for certain spine, oral-maxillofacial and
orthopedic trauma surgeries. For these surgeries, it can offer several benefits,
including eliminating the need to harvest bone from the patient’s body in a
secondary procedure, shorter operating times, and proven rates of fusion or bone

The active ingredient in Infuse Bone Graft – rhBMP-2 – is a manufactured version
of a protein already present in the body that promotes new bone growth. During
surgery, it is applied to an absorbable collagen sponge (ACS). The ACS is a
carrier to deliver the rhBMP-2 to the implant site and acts as a scaffold for
the formation of new bone, and it will resorb, or disappear, over time.  For
more information about Infuse Bone Graft, visit

The OLIF25 Procedure helps surgeons preserve the patient’s psoas muscle when
treating the L2-L5 levels of the spine.  Additionally, it gives surgeons easier
access around the patient’s iliac crest – enabling placement of an implant into
the disc space for anterior column support.  The OLIF51 Procedure provides
lateral access to the L5-S1 disc space and doesn’t require surgeons to flip the
patient from an anterior position during surgery.  OLIF Procedures incorporate
Medtronic’s comprehensive surgical platform of access, interbody, navigation,
fixation and biologic options.

Infuse Bone Graft is not indicated for use with a trans-psoas surgical
approach.  As with any surgery, a spinal fusion procedure with Infuse Bone Graft
/ Medtronic Interbody Fusion Device is not without risk.  A variety of
complications can occur.  These may occur in isolation or in combination.
Additional surgery may be needed to correct these complications.

A multimedia version of this release with downloadable media can be found here:

About Medtronic

Medtronic, headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 85,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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