The iO-Flex® System

The iO-Flex System®
Inside Out

The Intuitive Direction for Precision Decompression^®
With or Without Fusion

The iO-Flex^® System utilizes thin, flexible instruments to provide precision lumbar decompression from the “inside out.” The intuitive, controlled “over the wire” system is designed to:

Target and decompress bone and soft tissue in the foramen, lateral recess, and central canal
Preserve facet joint integrity, thus maintaining biomechanical stability¹ and bone for fusion fixation
Minimize muscle trauma by allowing decompression of up to 4 nerve roots through a single-point access

Decompression using the iO-Flex^® System may help:

Reduce OR time
Decrease hospital length of stay

Surgery from the Inside Out^®

3 Step Inside Out Efficiency

Accomodates open and tube-based access, unilateral or bilateral approach.


Step 1: Access Probe deploys across targeted impinging tissue to precisely deliver the wire	Step 2: Confirmation Neuro Check® device helps confirm the wire is dorsal to the nerve root	Step 3: Decompression Micro Blade Shaver® instrument performs precision removal of impinging bone and soft tissue

Step 1:
Access

Probe deploys across targeted impinging tissue to precisely deliver the wire

Step 2:
Confirmation

Neuro Check® device helps confirm the wire is dorsal to the nerve root

Step 3:
Decompression

Micro Blade Shaver® instrument performs precision removal of impinging bone and soft tissue

Stenosis Prior to reciprocation	Removal of impinging tissue following reciprocation
Assessment Standard probes and lateral fluoro, assess progression of decompression with the MicroBlade Shaver® instrument

Rapid, Direct, Controlled Decompression

Directly removes impinging ligament and bone with controlled bimanual reciprocations
Can be used in patients with all severities of symptomatic, single and multi-level stenosis

The iO-Flex^® System’s “inside out” approach vs. traditional rigid instruments:^1,4,5,6

Offers better access to lateral recess and foramen
Preserves facet joints and lamina
Maintains biomechanical stability
Offers greater preservation of bone for fusion fixation

Facet Preservation & Decompression Quality:
A quantitative comparison of standard tools vs. iO-Flex®³

(click to enlarge)

Decompression of the lateral recess and foramen with the iO-Flex™ system
has minimal impact on facet joint area as compared to traditional instruments

Tissue Sparing Single-Point Access

Decompression of up to 4 nerve roots through a single access point reduces muscle trauma.⁷

Cross sectional view with vertebral bodies removed at pedicles (view from anterior) demonstrates decompression of bone and soft tissue by each of the 4 passes.

Discover the Upside of the Inside Out^®

Baxano is committed to providing iO-Flex^® Services including MicroBlade Shaver^® and Neuro Check^SM Medical Services, such as:

Comprehensive training programs
Easy-to-use physician and staff educational materials
Patient education materials
Quality service and support

For more information

References

^1. Lauryssen, C., Technical Advances in Minimally Invasive Surgery: Direct Decompression for Lumbar Spinal Stenosis. Spine 2010;35:S293
^2. Weinstein et al. Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. New England Journal of Medicine 2009; 91:1295-305
^3. Data on file from an IRB approved retrospective chart review,
^4. Data on file from a cadaver study comparing the iO-Flex^® System and standard instruments,
^5. Cosar et al. SAS Journal 2007;1:135-142,
^6. Haher et al. Spine 1994;23:2667-2671,
^7. Rahman et al. Minim Invas Neurosurg 2008;51:100-105