Situation Overview
Over 3 million aging Americans experience pain from lumbar spinal stenosis (lumbar stenosis) each year. It is a degenerative condition caused by the overgrowth of bone and tissue that press on nerves as they exit the spine and travel to the lower half of the body. Symptoms can include lower back pain or shooting pain, weakness, numbness or tingling in the buttocks and legs. Lumbar stenosis can occur in three distinct areas, depending on the location of the overgrown bone and tissue. If left untreated, spinal stenosis will worsen over time.

1. The three distinct areas of the spine where lumbar stenosis occur are central canal, lateral recess and neural foramen
2. Recent research shows lumbar stenosis most commonly occurs in more than one location (>76%)
3. Lumbar stenosis is the most common reason for spine surgery in people over 65 years of age
4. The majority of lumbar stenosis patients have good results with decompression surgery, and most leave the hospital in a few days and return to normal activities within a few weeks

Challenge
Limitations exist with traditional surgical instruments used in decompression surgery. These knife-like, rigid instruments must cut through bone and tissue in a straight line to access the three parts of the spine where overgrown bone and tissue compress nerves, often requiring the removal of healthy pieces of the patient's spine needed for stability.
Because traditional decompression instruments, as well as newer "out-patient" procedures, are limited in their ability to reach and remove all three areas of lumbar stenosis, patients may experience a recurrence of pain, which may lead to another operation.  

The stabilizing joints of the spine that help link vertebrae together are known as facet joints. Removing as little as 30% of the facet joint to access the area of the patient's lumbar stenosis during traditional decompression can lead to a complication called instability of the spine and the possible need for a spinal fusion procedure to stabilize the unstable joint

Failure to remove all lumbar stenosis during a decompression procedure, especially in hard to reach areas, accounts for up to 58% of poor surgical outcomes, including continued or recurring pain, weakness, tingling and numbness. As a result patients may need to undergo additional treatment and possibly another surgical procedure  

Solution
The iO-Flex System is the first minimally invasive set of flexible instruments designed to target lumbar stenosis in all three areas, with minimal disruption to the patient's healthy anatomy.  The iO-Flex System is designed to help surgeons tailor the decompression based on the location of each patient's lumbar stenosis.  It is the only treatment alternative that is able to reach and relieve pressure surrounding up to two nerves on each side of the spine, through one small incision.

To reach lumbar stenosis in all three areas, a fine surgical wire is used to guide the thin iO-Flex shaver instrument to the location of the overgrown bone and tissue. This allows surgeons to simply shave away the overgrown bone and tissue from the inside out.
 
Because the iO-Flex System is designed to be less invasive and less traumatic, it may lead to shorter operating times, hospital stays and recovery times compared to traditional decompression

HCP Message: The iO-Flex bone sparing instruments preserve the option for future surgical procedures, if needed


Charles Kanaly, MD of Providence, Rhode Island is performing decompression with the iO-Flex System to help relieve the symptoms of lumbar stenosis for patients in the Providence area.