iO-Flex™

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

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

Access Probe

Step 2, iO-Flex System

Step 3, iO-Flex System

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

Preservation of Facet Integrity

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

iO-Flex System

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

4 Passes

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:

• Comprehensive training programs

• Easy-to-use physician and staff educational materials

• Patient education materials

• Quality service and support

For more information

References

1. Bresnahan et al. Spine 2008 34;1:17-23, 2. Data on file from Baxano US Pilot study and SPORT foraminal stenosis subgroup analysis, 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