Are you over 50? Do you have back and leg pain when you stand or walk? Does the pain decrease when you sit? Have you been diagnosed as having lumbar spinal stenosis (LSS)?
This group of circumstances can be relieved by an implant (well, not the age thing, but the pain),according toSt. Francis Medical Technologies (Alameda, California), officially giving “coming out“ launch of its product in the U.S. at the annual meeting of the American Association of Neurological Surgeons (Rolling Meadows, Illinois) in San Francisco.
The product: the X Stop Interspinous Process Decompression (IPD) System, a titanium alloy implant.
St. Francis calls it the first and only FDA-approved, non-fusion treatment demonstrated to improve symptom severity and physical function for patients with LSS, a common spinal problem experienced mainly by the middle-aged and elderly and often associated with debilitating pain in the back and legs.
The company estimates that LSS may affect over two million Americans and says that the X Stop IPD is getting positive acceptance by the surgical community it is training. Better yet, the implantation procedure is much less invasive that the worst-case scenario of surgery, according to Kevin Sidow, president and CEO of St. Francis Medical.
The device was FDA approved in November of 2005 and since then the company has been training surgeons in its use, thus far a total of 500, Sidow told Medical Device Daily.
As to projected uptake, he notes that every training session the company has set is overbooked and that it is getting strong positive feedback at the AANS meeting.
Inserted through a small incision rather than by open surgery, the X Stop is placed between two bones called the spinous processes of the symptomatic discs in the low back. The intent of its design is 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.
Those systems are worse when a person is standing and are relieved when spaces in the spine are created by sitting. Thus, the X Stop, he says, essentially serves to replicate the sitting posture.
The less-invasive procedure can be performed under local anesthesia, taking less than an hour, he notes. And since the device is not fixed to any bony structures, the procedure does not result in fusion and is completely reversible, thus allowing for future therapeutic alternatives, if needed, such as a laminectomy.
And as opposed to weeks (or even months) of recovery following surgical procedures to correct LSS, the X Stop allows for a patient's return to regular activities in about a week.
Sidow emphasizes the important benefits of the X Stop for a condition that can force an increasing sedentary existence, which in turn produces a cascade of follow-on complications. And St. Francis Medical says that LSS is the most common reason for back surgery in people over the age of 50 in the U.S. In 1995 it was reported that 1.2 million physician's office visits were related to symptoms of LSS.
“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 Zucherman, MD, co-inventor of the X Stop.
Happily for the company the procedure reimbursed by the Centers for Medicare & Medicaid Services and by most major health plans, it says. “Upon pre-certification, greater than 80% of payors are extending benefits for coverage.“
The X Stop has been available in Europe and Japan since 2001. More than 7,000 X Stop devices have been implanted worldwide.
St. Francis is engaged in the discovery, development, manufacturing and marketing of novel treatments for degenerative spinal disorders worldwide.
In other news from the meeting:
Accuray (Sunnyvale, California), a leading developer of robotic radiosurgery, reported that spinal tumor treatments with the CyberKnife Robotic Radiosurgery System grew more than 75% since the introduction of the Xsight Spine Tracking System in April 2005. The results of two clinical studies presented serve, it said, “as further support for the effectiveness of the CyberKnife system for treating tumors in the spine.“
Peter Gerszten, MD, associate professor of neurological surgery and radiation oncology at the University of Pittsburgh Medical Center , presented the results of an 87-patient study evaluating the clinical efficacy of single-fraction radiosurgery for the treatment of spinal metastases from lung cancer. The results demonstrated that spinal tumor patients who underwent treatment with the CyberKnife system experienced long-term tumor control, with 90% of patients experiencing long-term pain reduction.
Gerszten said, “We have known for some time that radiosurgery is an effective treatment for intracranial tumors. We can now offer an effective radiosurgery treatment option for our patients with spinal tumors, as well.“
John Sinclair, MD, division of neurosurgery, Ottawa Hospital , presented the results of a study using the CyberKnife System for the treatment of intramedullary spinal cord arteriovenous malformations (AVMs) at Stanford University . Data showed that treating patients with spinal cord AVMs using the CyberKnife System resulted in significantly reducing the size of AVMs.
A differentiating feature of the CyberKnife System for the treatment of spinal tumors is the Xsight Spine Tracking System, a non-invasive tracking system that enables clinicians to more accurately and easily access and treat tumors in or near spinal structures without implanting radiographic markers or fiducials.
Eric Lindquist, chief marketing officer of Accuray, said, “As the only robotic radiosurgery spinal tumor treatment option that doesn't require the placement of fiducials, clinicians are also embracing the efficiencies of the Accuray's Xsight system, which ultimately enables them to treat more patients than ever before.“
Accuray reports more than 100 CyberKnife Systems purchased by medical centers throughout the world and a large body of peer-reviewed papers supports its clinical practice. It said that, to date, the CyberKnife has treated more than 20,000 patients worldwide.