Healthcare Industry News: St. Francis Medical Technologies
News Release - April 24, 2006
St. Francis Medical Technologies Announces National Availability of First and Only FDA Approved, Non-Fusion Treatment for Common Degenerative Spine DisorderPatients Coast-to-Coast in the United States Now Have Access to Surgeons Performing Break-Through Treatment
SAN FRANCISCO--(HSMN NewsFeed)--April 24, 2006--St. Francis Medical Technologies, Inc.® announced today the national launch of its patented X STOP® Interspinous Process Decompression (IPD®) System ("X STOP"). The announcement was made at The American Association of Neurological Surgeons (AANS) 2006 Annual Meeting in San Francisco.
Patients in all four corners of the contiguous Unites States suffering from lumbar spinal stenosis (LSS) now have access to a minimally invasive, lower risk surgical alternative to relieve their symptoms. The X STOP, a titanium alloy implant, is the first and only FDA approved, non-fusion treatment proven to improve symptom severity and physical function for patients with LSS. LSS is a common spinal problem experienced mainly by the middle-aged and elderly population and often associated with debilitating pain in the back and legs. LSS may affect over two million Americans.
"This procedure fills a gap in the continuum of care, that, until now, required patients to make the leap from conservative therapies, such as analgesics and injections, straight to invasive surgery with a laminectomy," said James F. Zucherman, M.D., co-inventor of the X STOP.
Since its FDA approval in November 2005, St. Francis has trained more than 500 spine surgeons around the country in the X STOP IPD procedure. It is reimbursed by the Centers for Medicare & Medicaid Services and by most major health plans. Upon pre-certification, greater than 80% of payors are extending benefits for coverage.
"Surgeons have been very responsive to using X STOP as a therapy for their patients," said Kevin Sidow, president and chief executive officer of St. Francis Medical Technologies. "As the only minimally invasive device of its kind on the market, doctors see the value that the X STOP procedure can offer their patients. The X STOP is clinically proven to rapidly relieve patients' symptoms and is well-poised to become the first-line surgical intervention for LSS patients."
Inserted through a small incision, the X STOP is placed between two bones called spinous processes of the symptomatic discs in the low back. The X STOP is designed to limit extension of the lumbar spine, and keep open the canal in the lower spine that carries nerves to the legs, thereby relieving symptoms.
The device can be surgically implanted in a minimally invasive procedure that is typically performed with local anesthesia in less than an hour. As it is not fixed to any bony structures, the X STOP procedure does not result in fusion and is completely reversible without compromising any therapeutic alternatives, including laminectomy.
Lumbar spinal stenosis is a medical condition that is a result of the narrowing of the spinal canal. LSS is the most common reason for back surgery in people over the age of 50 in the United States(1). In 1995 it was reported that 1.2 million physician's office visits were related to symptoms of LSS(2), this number is over 2 million today(3).
The X STOP has been available in Europe and Japan since 2001, more than 7,000 X STOP devices have been implanted worldwide.
About St. Francis Medical Technologies
St. Francis Medical Technologies is a privately held company based in Alameda, Calif. engaged in the discovery, development, manufacturing and marketing of novel treatments for degenerative spinal disorders worldwide. In November 2005, St. Francis received FDA approval for the X STOP, the first FDA-approved interspinous process implant to treat Lumbar Spinal Stenosis (LSS), a degenerative spinal disorder that may affect over two million Americans. As a result, patients and healthcare professionals finally have a safe and effective alternative to more aggressive, riskier procedures. For more information, please visit: www.sfmt.com.
(1) The Center for the Evaluative Clinical Sciences, Dartmouth Medical School. The Dartmouth Atlas of Musculoskeletal Health Care. The Trustees of Dartmouth College, 2000
(2) The Hart LG, Deyo RA, Cherkin DC. Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. national survey. Spine 1995;20:11-9.
(3) The Ortho FactBook(TM); U.S. 5th Edition; Solucient, LLC and Verispan, LLC
Source: St. Francis Medical Technologies
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