FDA Approves Spinal Implant Invented at St. Mary's Medical Center; New Procedure Offers Alternative to Invasive Surgery, Quicker Recovery Time

SAN FRANCISCO--()--Nov. 22, 2005--The U.S. Food and Drug Administration (FDA) announced today the approval of X STOP(R), 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.(R), 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.

For more info visit www.stmarysmedicalcenter.org.

Contacts

for St. Mary's Medical Center
Erin Bartlett, 415-750-5787 (Office) or
415-254-3379 (Cellular)
erin.bartlett@chw.edu

Contacts

for St. Mary's Medical Center
Erin Bartlett, 415-750-5787 (Office) or
415-254-3379 (Cellular)
erin.bartlett@chw.edu