Greensburg, Pa., a principal investigator in
The Subqstim II pivotal study is the latest in a series of clinical trials sponsored by
Medtronic to generate a comprehensive
portfolio of evidence demonstrating the
clinical and economic value of its neurostimulation systems for the management
of chronic pain. Medtronic recently initiated the Subqstim I post-market study
in Europe, Israel, Australia and Canada
to evaluate the effectiveness of PNS plus
optimal medical management (OMM) for
low back pain, compared to OMM alone
in patients with failed back surgery syndrome (FBSS). In January, the company
announced the beginning of Promise, a
prospective, randomized study of multicolumn implantable lead stimulation for
predominant low back pain. Promise is
the first-ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy with Specify 5-6-5
multicolumn surgical leads plus OMM,
to OMM alone in patients with FBSS and
predominant low back pain.
“Chronic back pain affects a significant
number of adults in the United States, and
if the Subqstim II pivotal trial results are
positive, we plan to pursue FDA approval
to make this potential treatment option
available to patients who may benefit,”
said Julie Foster, general manager and vice
president of pain stimulation and targeted drug delivery in the neuromodulation
business of Medtronic.
It is estimated that 100 million U.S.
adults live with chronic pain, and it is the
most prevalent type of chronic pain, affecting approximately 10 percent of the
U.S. population. Many patients suffering
from chronic pain following spine surgery
receive oral medications and other therapy, but clinical experience finds many of
these patients fail to obtain adequate relief
and will require additional interventions.
Half Page Advert_XL Precision Technologies 24/04/2013 17: 10 Page 1
Medtronic joins other companies in
the multi-billion dollar neurostimulation
market, including Boston Scientific, which
recently gained FDA approval for Precision
Spectra, its spinal cord stimulation device.
Prime Time Medical
Sanomedics International Holdings Inc., a
Miami, Fla.-based maker of devices for the
treatment of sleep disorders, has agreed to
a deal to buy Prime Time Medical Inc., a
home medical equipment provider based
in Largo, Fla. The acquisition is valued at
Sanomedics did not disclose how it will
fund the acquisition.
Prime Time’s revenue for fiscal year
2012 was approximately $5 million.
“Prime Time Medical . . . is another step
in our continual process of expanding our
portfolio while we implement our growth
strategy,” said Keith Houlihan, Sanomed-
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