St. Francis Gets FDA Approval
BY JOHN MCCORMICK, NOVEMBER 22, 2005
After and long and contentious approval process with the FDA, St. Francis Medical Technologies, Inc. announced this morning that it has received FDA approval to market its X STOP Interspinous Process Decompression System.
X STOP (and the interpinous processes paradigm generally) is well known to spine surgeons and the industry. Such devices are reversible, can be surgically implanted with minimally invasive techniques, use local anesthesia and importantly: the procedure can be done with speed with patients often leaving the hospital on the same day.
The X STOP is used for relieving the symptoms of lumbar spinal stenosis. It therefore represents a compelling alternative to laminectomy. It also fills white space in the continuum of care between more conservative therapies such as pain killers and major spine surgery.
