1. Spinal Stabilization System By Matthew Leon and Katelyn Kondra
LimiFlex
Spinal Stabilization System
By Matthew Leon and Katelyn Kondra

2. Simpirica Spine Established: 2006 San Carlo, CA
EU: Product Distributor
US: Investigational Use
Ian Bennett
-Ian Bennett = Founder
Mechanical Engineer, Medical Device Designer, Entrepreneur
Stanford BS, MS – Mechanical Engineering ( )

3. Lumbar Spinal Stenosis
Narrowing/Compression of the Spinal Cord and associated nerves
Pain and weakness
US: 8 – 11 %
2.4 Million by 2021
MRI : Definitive Diagnosis
Bicycle Test of Van Gelderen
As the “baby boomers” age, an estimated 2.4 million Americans will be affected by LSS by 2021
Signs and Sypmtoms
pain, weakness, and tingling of the legs and "radiation down the posterior part of the leg to the feet”
Additional symptoms in the legs may be fatigue, heaviness, weakness, a sensation of tingling, pricking, or numbness and leg cramps, as well as bladder symptoms
- Typically occurs in the aging spine of individuals beyond their fifth decade of life
- MRI is the only Definitive diagnosis
-The bicycle test is a simple procedure in which the patient is asked to pedal on a stationary bicycle. LSS vs. peripheral vascular disease, the patient will experience Claudication both ( decreased blood flow to Lower extremities)
flexion relieves claudication if LSS

4. Degenerative Spondylolisthesis
“Slipped Vertebral Body”
L3-L4 or L4-L5
> 50 years old
Females to Males (3:1)
Facet Joint Aging and Flexion
3-Step diagnosis process
As the facet joints age, they can become incompetent and allow too much flexion, allowing one vertebral body to slip forward on the other.
3 step diagnosis process for
Medical History – primarily a review of the patient’s symptoms and what makes the symptoms better or worse.
Physical Examination – the patient is examined for physical symptoms, such as range of motion, flexibility, any muscle weakness or neurological symptoms.
Diagnostic Tests – if a spondylolisthesis is suspected after the medical history and physical exam, an X-ray may be done to confirm the diagnosis and/or rule out other possible causes of the patient’s symptoms. Based on the results of the X-ray, further tests may be ordered, such as an MRI scan, to gain additional insights.

5. Target Audience
Patients who could benefit from additional stabilization
400,000 per year suffer from instability and pain with lumbar flexion
Flexion: Bending forward  separation of spinous processes
Most exercised component of spinal motion
Problematic for those considering/undergone surgery
-Most common type of spinal motion used in humans
-400K Around the World -

6. Pre-existing Therapies
Non-Surgical options
Physical Therapy
Immobilizing Brace
NSAIDS
Activity Modification
Spinal Epidural Injections
Surgical Options
Lumbar Laminectomy
Lumbar Decompression
Spinal Fusion
Lumbar Laminectomy – Lamina Removed
Lumbar Decompression – Remove bone and soft tissue that are compressing nerves/spinal cord; screws, rods, bone grafts used to immobilize
Spinal Fusion – Use bone graft to fuse two adjacent vertebrae

7. Limiflex Device Makeup
Two dynamic spring-like titanium rods connected by two Ultra-high Molecular Weight Polyethylene (UHMWPE) straps.
Attachment mechanism for the straps are integrated into the rods
Loops around 2 spinous processes
Fin-like projections at the back of each vertebrae
No pedicle screws needed to anchor
Rods attached by screws to straps which encircle process
Permanent implant
-Used in conjuncture with decompressions eliminates the need for stabilizing rods, screws, grafts
-Non-invasive to healthy and in tact bones
-No need for Fusion

8. Limiflex Visual

9. Mechanism of Action
Designed to resist separation via progressive tensile forces applied by straps
Reduces segmental flexion and increases facet engagement
Extension, rotation, lateral bending are minimally affected
Device does not induce hyperextension
Physiologic center of rotation of treated segments maintained
-Tensile Forces (class application!!!)

10. Costs: Post-Op and Monetary
4-5 days in-hospital
4-6 weeks on work leave; 12 weeks for heavy lifting profession
Physical therapy and Prescription medications
Deep and Superficial stitches (5-10 days for removal)
Post-op movement to reduce risk of thrombosis
Costs and Insurance coverage are still under review due to investigational status in the United States
-These Post-op regulations pertain to spinal decompression
-It is thought, that limiflex will help to reduce the cost and length of rehabilitation from this decompression procedure
$22 MILLION INVESTED IN THE CURRENT US TRIALS COSTS HAVE TO MAKE UP FOR IT

11. Device Impact Reduces pain and instability with lumbar flexion
Minimally invasive treatment option
Dynamic stabilization
Flexion-restricting
Allows for return to more active lifestyle
-As compared to the spinal fusion AKA PLF
-One Surgery – decompression first and then limiflex
-Surgery consists of decompression followed by device implantation

12. Device Limitations/Complications
Incision-site infection
Surgical complications
Not indicated for scoliosis
Thrombosis
Failed Back Syndrome
Recurring Pain: decompression surgery does not correct underlying degenerative damage
-Mention

13. Current Status of Device: EU
Commercially available since January (CE Marked)
Used in conjunction with spinal decompression treatment for stenosis
Over 300 successful implants currently being studied

14. Current Status of Device: US
Recent IDE pivotal study approved
Randomized controlled study
Treatment group: Decompression + LimiFlex
Control group: decompression + posterolateral fusion (PLF)
24 month study
Procedure
-Remove bone and soft tissue that are compressing nerves/spinal cord (Compression) and the device is inserted instead of PLF
-Restricts flexion

15. Biomechanical Testing
Dr. Avinash Patwardhan of Loyola University
UCSF
Loads applied by device < Loads required for spinous process fracture
-Dr. Patwardhan (used cadavers)
Reduced Flexional ROM
Increased Facet Engagement
Decreased Segmental translocation
-UCSF
Even when 50% of Spinous process was removed

16. Testing Results
-Illustrates stabilization beyond pre-op condition

17. Limiflex: The better choice
Unlike other spinal instrumentation…
Bears increased loads only when spinous processes separate
Doesn’t bear/transmit axial compressive loads like other instrumentation
No impulse loads generated during activities like walking and running
-Lets sell them on this

18. Sources http://www.simpirica.com/us-en/index.php