St. Jude Medical Announces US Launch and First Commercial Implants of DRG Stimulation Therapy

Availability of the dorsal root ganglion (DRG) therapy represents an
important milestone in the treatment of chronic intractable pain
conditions due to complex regional pain syndrome I and II


ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc., a global medical device company, today announced
the U.S. launch and first post-approval implants of the St.
Jude Medical Axium™ Neurostimulator System
for dorsal root ganglion
(DRG) stimulation to treat patients with chronic pain that has been hard
to control with traditional spinal cord stimulation (SCS). First
commercial implants of the device occurred at the Center for Pain Relief
in Charleston, W.Va. by Dr. Timothy Deer, and at the Sutter Santa Rosa
Surgery and Endoscopy Center in Santa Rosa, Calif., by Dr. Jason Pope.

In the coming weeks, DRG implants will occur in half the states in the
United States. St. Jude Medical has already partnered with implanting
chronic pain specialists who will conduct more than 100 procedures in 59
centers nationwide in the first month after launch. Over the course of
the year, the company expects to have more than 300 physicians across
the country trained to effectively deliver DRG therapy to patients in
immediate need of targeted stimulation to alleviate chronic pain
resulting from moderate to severe chronic intractable pain of the lower
limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types
I and II.

“Although many chronic pain patients can find relief from a traditional
spinal cord stimulation device, many patients suffering from focal
chronic pain including CRPS I and II don’t receive adequate pain relief
from spinal cord stimulation,” Dr. Deer said. “Adding dorsal root
ganglion stimulation with the Axium neurostimulator system to my
therapeutic arsenal is an exciting step in the treatment of chronic
intractable pain of the groin, knee and foot. I’m impressed with the
speed in which I am able to reach and stimulate the dorsal root
ganglion, something I was unable to do before the Axium neurostimulator
system. For the first time, I now have a device designed specifically
for the large and growing number of under-treated chronic pain patients
I could not previously serve.”

Stimulation of the DRG, a spinal structure densely populated with
sensory nerves that transmit information to the brain via the spinal
cord, allows physicians to treat the specific areas of the body where
pain occurs. The St. Jude Medical Axium neurostimulator system is the
only therapeutic approach of its kind designed to treat moderate to
severe chronic intractable pain of the lower limbs in adult patients
with CRPS. Patients with CRPS are often underserved by conventional
medical management and many interventional pain procedures. Many
patients have tried multiple treatment options without receiving
adequate pain relief.

“Stimulation of the dorsal root ganglion is the first therapy option
designed specifically for patients suffering from complex regional pain
syndromes. This serious and traditionally challenging to treat chronic
pain condition can occur from complications to recovery from surgeries
such as knee arthroscopy, foot surgery or hernia surgery,” Dr. Pope
said. “Having a treatment option rooted in clinical evidence
fundamentally changes our approach to treating patients. I am thrilled
to be among the first in the United States to offer previously
underserved patients this revolutionary technology.”

According to the Institute
of Medicine
, chronic pain affects more than 100 million Americans,
an incidence rate which outpaces heart disease, cancer and diabetes
combined. Neuropathic pain represents one of the most prevalent yet
under-treated forms of chronic pain in the United States, with an
estimated one in every 10 adults over the age of 30 suffering from the
condition.

“Since the approval of dorsal root ganglion stimulation with the Axium
system in February 2016, we have focused on a strategic rollout with a
disciplined training program for physicians across the country. We
believe this approach ensures patient access to this highly effective
new therapy to help manage their chronic pain,” said Dr. Allen Burton,
medical director of neuromodulation and vice president of medical
affairs at St. Jude Medical. “The first Axium system implants in the
United States reflect our ongoing commitment to working with our
physician partners to deliver on our promise to transform the treatment
of chronic pain.”

Initial results from the ACCURATE
IDE study
, the largest study to date evaluating patients suffering
from neuropathic chronic intractable pain associated with CRPS I and II
or peripheral causalgia (PC), showed DRG stimulation provided patients
with superior pain relief over traditional tonic SCS. Approval of DRG
stimulation with the St. Jude Medical Axium Neurostimulator System was
based in part on the results of this study in which patients were
randomized to receive either DRG stimulation delivered by the Axium
neurostimulator system or traditional tonic SCS therapy delivered by a
competitor’s system.

For more information about St. Jude Medical’s focus on the treatment of
chronic pain, visit the St.
Jude Medical Chronic Pain Media Kit
or the St.
Jude Medical PULSE Blog
.

Information for patients to learn more about chronic pain can be found
at www.sjm.com/pain.

About St. Jude Medical

St. Jude Medical is a leading global medical device manufacturer and is
dedicated to transforming the treatment of some of the world’s most
expensive epidemic diseases. The company does this by developing
cost-effective medical technologies that save and improve lives of
patients around the world. Headquartered in St. Paul, Minn., St. Jude
Medical has five major areas of focus that include heart failure, atrial
fibrillation, neuromodulation, traditional cardiac rhythm management,
and cardiovascular. For more information, please visit sjm.com
or follow us on Twitter @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that involve
risks and uncertainties. Such forward-looking statements include the
expectations, plans and prospects for the Company, including potential
clinical successes, anticipated regulatory approvals and future product
launches, and projected revenues, margins, earnings and market shares.
The statements made by the Company are based upon management’s current
expectations and are subject to certain risks and uncertainties that
could cause actual results to differ materially from those described in
the forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control and the
risk factors and other cautionary statements described in the Company’s
filings with the SEC, including those described in the Risk Factors and
Cautionary Statements sections of the Company’s Annual Report on Form
10-K for the fiscal year ended January 2, 2016. The Company does not
intend to update these statements and undertakes no duty to any person
to provide any such update under any circumstance.

Contacts

St. Jude Medical, Inc.
J.C. Weigelt, 651 756 4347
Investor
Relations
jweigelt@sjm.com
Laurel
Hood, 651 756 2853
Media Relations
LHood02@sjm.com