Healthcare Industry News:  St. Francis Medical Technologies 

Devices Orthopaedic Neurosurgery

 News Release - September 26, 2006

Co-Inventor of X STOP Selected to Present on Novel Technology at North American Spine Society Annual Meeting

One Year Post-FDA Approval, More Than 1,000 Spine Surgeons Trained Nationwide

SAN FRANCISCO--(HSMN NewsFeed)--St. Francis Medical Technologies, Inc.® announced today that James F. Zucherman, MD, co-inventor of the X STOP® Interspinous Process Decompression (IPD®) System ("X STOP"), the first and only FDA approved interspinous process device, has been selected as a featured presenter as part of an educational session on novel technology at the 21st annual meeting of the North American Spine Society (NASS) taking place September 26 - 30 in Seattle, Wash.

Dr. Zucherman's presentation on IPDs is part of the NASS pre-meeting educational course titled "Adjacent Segment Degeneration: Novel Technology and the Preservation of the Adjacent Segment" scheduled for Tuesday, September 26 at 8:00 a.m. (PDT). His participation in this prestigious event caps off a momentous year for the company and comes on the heels of an important reimbursement increase and the publication of two clinical papers on study results that further demonstrate the X STOP's clinical value and positive outcomes for patients suffering from lumbar spinal stenosis (LSS).

"Over the past year, the X STOP has continued to prove its value to spine surgeons, enabling them to provide significant benefits to their patients suffering from lumbar spinal stenosis and reducing the need for invasive surgery," said Kevin Sidow, president and chief executive officer of St. Francis Medical Technologies. "The value of the X STOP has been further demonstrated through the positive responses we've received from patients who experienced rapid relief from their LSS symptoms after undergoing the procedure."

Since the X STOP received approval from the U.S. Food and Drug Administration (FDA) in November 2005, St. Francis has trained more than 1,000 spine surgeons around the country in the X STOP IPD procedure and more than 11,000 implants have been inserted worldwide. It is reimbursed by the Centers for Medicare and Medicaid Services (CMS) and by most major health plans, providing widespread access to the procedure for patients from coast to coast.

In August, CMS approved a special add-on payment for hospitals that provide the X STOP procedure, making it the only device this year to receive this approval. The provision enhances patient access to the X STOP treatment as part of CMS' intention to provide additional funding for new technologies that meet a cost threshold and demonstrate a substantial clinical improvement over existing treatment options.

In July, the Journal of Spinal Disorders & Techniques published results from a four-year follow-up study on a subset of patients from the multi-center clinical trial that showed that patients suffering from LSS have symptom relief and improved physical functioning with the X STOP and remain stable over time.

This publication came on the heels of the publication of results from the two-year pivotal study that showed significantly greater improvement in a subset of patients suffering from LSS with spondylolisthesis who received the X STOP procedure compared to those who received steroid injections and other non-operative care (Journal of Neurosurgery: Spine, May 2006). These results are significant for this subset of patients because they historically required invasive procedures and now have a minimally invasive option that is shown to provide better clinical outcomes.

"The X STOP's positive clinical outcomes and its ability to provide relief from the symptoms of LSS is again demonstrated in these results," said Dr. Zucherman. "The X STOP provides a new option for patients who have not received relief through therapeutic treatments and are unable or unwilling to have invasive procedures such as fusion or laminectomy."

About the X STOP

The X STOP® Interspinous Process Decompression (IPD®) System ("X STOP") is a titanium alloy implant that was approved by the FDA in November 2005 as the first and only non-fusion treatment to improve symptom severity and physical function for patients with LSS. X STOP fills a gap in the continuum of care for LSS sufferers that, until now, required patients to leap from conservative therapies, such as analgesics and injections, straight to laminectomy, an invasive procedure that is considered the current surgical standard of care. Clinically proven to relieve patients' symptoms, the X STOP procedure 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 vertebra 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.

The X STOP has been commercially available in Europe since 2001.

About LSS

LSS is the most common reason for back surgery in people over the age of 50 in the United States. It is a common spinal problem that results from a narrowing in the lumbar spinal canal that carries nerves to the legs. As this space in the lower spine shrinks, the nerves are squeezed causing debilitating pain in the back, legs and buttocks. In 1995 it was reported that 1.2 million physicians' office visits were related to symptoms of LSS and this number was estimated to be over 2.3 million in 2003.

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.


Source: St. Francis Medical Technologies

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