San Francisco, CA
November 22, 2005
FDA Approves Spinal
Implant Invented at St.
Mary's
Medical
Center: New Procedure Offers Alternative
to
Invasive Surgery, Quicker Recovery Time
The U.S. Food and Drug Administration (FDA)
announced today the approval of X STOP®, an innovative new
spinal implant invented at St. Mary's Medical Center, which will be
the exclusive United States training center for this new low-risk
medical procedure.
"The invention of the X STOP exemplifies our
commitment to continually providing patients with innovative
medicine and technology," said Ken Steele, president of St. Mary's
Medical Center. "We are delighted to be able to perform the first X
STOP procedures here at St. Mary's Medical Center and begin
providing patients with a minimally invasive option that will allow
them to quickly return to enjoying a full life again."
James Zucherman, MD, medical director of St.
Mary's Spine Center and Ken Hsu, MD, director of spine surgery at
St. Mary's Spine Center, together invented the X STOP in response
to the need for treatment options for a common condition called
lumbar spinal stenosis, caused by age-related narrowing of the
spine resulting in pressure on the spinal nerves.
Four out of five adults will experience some
kind of back pain in their lifetime. For many, spinal stenosis is
an every day painful reality. The condition, characterized by
symptoms of back pain and leg pain, numbness or weakness is the
most common cause of back surgery for adults over the age of 50,
affecting an estimated 400,000 Americans.
In 1995, medical research showed that 1.2
million physician's office visits were related to symptoms of
spinal stenosis and in 2003 there were as many as 2.3 million. And
it is estimated that more than 125,000 decompressive laminectomy
procedures, a more invasive surgical approach, were performed for
spinal stenosis in 2003.
"The financial impact in terms of health care
dollars and lost work hours as a result of back pain reaches
billions of dollars each year in this country," said Steele.
"Rapidly expanding numbers of people over the age of 50 represent
an unprecedented global health care challenge and back pain is a
significant health care issue."
Now, thanks to this innovative new spinal
implant, many who suffer from spinal stenosis will have the chance
to return to normal, active lives. "In the past, patients had two
polar opposite choices for treatment," said Dr. Zucherman. "If
conservative therapies such as medication and injections were not
successful, the only other alternative was invasive surgery."
Prior to the X STOP, which is manufactured by
the Alameda, Calif.-based company St. Francis Medical Technologies,
Inc.®, the surgical option called laminectomy, required
removing parts of the bone and tissue to reduce pressure on the
nerves and sometimes spinal fusions were necessary.
Now, X STOP offers patients a new option,
which is safer and more effective. The implant opens spaces in the
lower spine to relieve pressure on the nerves, requires a minimally
invasive procedure that is usually performed in about an hour under
local anesthesia and mild sedation allowing many patients to return
home in about a day.
"Many patients suffering from spinal stenosis
are reluctant to undergo invasive surgery due to age or other
health conditions," said Dr. Hsu. "X STOP fills the gap in the
continuum of care for patients with spinal stenosis and offers a
minimally invasive, safer alternative which is also very
effective."
The procedure is an excellent option for
patients who do not respond to conservative therapies, are unable
to undergo the risks of major surgery and want to return to
functioning pain-free as soon as possible.
In clinical studies, many patients who have
undergone the X STOP procedure experienced immediate symptom relief
and the recovery period is approximately two weeks. Outcomes from X
STOP are clinically proven to be equal to that of laminectomy
surgery, yet operative time, blood loss and complications are much
lower.
Approved in Europe and Japan in 2001, the
device has been successfully implanted in more than 4,000 patients
to date, plus an additional 100 patients during the clinical trials
at St. Mary's Medical Center. The recent FDA approval will now
allow patients in the United States to benefit from the implant.
Performing the first surgery since receiving FDA approval, St.
Mary's Medical Center will begin providing relief for back pain
suffers starting Wednesday, November 23.
The Spine Center at St. Mary's Medical Center
has provided comprehensive care for spine conditions for more than
30 years. A multi-disciplinary team composed of spine surgeons and
non-surgical spine specialists offer patients the latest
treatments, while working to develop innovative new procedures and
technologies such as X STOP.
"Our passion is innovative medicine," said Dr.
Hsu. "We want to be able to treat even the most difficult spine
problems using the least invasive approach and return our patients
quickly to pain-free, active lives."
For nearly 150 years, St. Mary's Medical
Center has provided the Bay Area with compassionate, personalized
care combined with the latest advances in medical care and
cutting-edge technology. St. Mary's is a full-service acute care
facility with more than 575 physicians and 1500 employees who
provide high-quality and affordable health care services to the Bay
Area community and patients from around the world. Home to advanced
medical practices, such as the nation's first digital cardiac
catheterization laboratory, pioneering spine surgery and
comprehensive rehabilitation, St. Mary's Medical Center is one of
San Francisco's leading hospitals, offering patients a full range
of outpatient and inpatient services delivered with the human
touch.
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