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AIMIS procedures annex 1
1. American Institute of Minimally Invasive Spine Surgery
SUMMARY NOTES ON MIS SPINE TECHNOLOGIES ANNEX 1
Treatment Options
When spine problems develop due to injury, aging, wear and tear, or deformity, treatment options should
focus on the actual source of the problem with the least amount of interruption to a patient’s life.
Medication, physical therapy, bracing or lifestyle changes may successfully treat problems caused by slipped
discs, slipped vertebrae or curvature of the spine. For many people, though, surgery may be the best option
to treat pain or deformity.
“Open Surgery” vs Minimally Invasive Surgery
The most beneficial aspect of traditional open surgery is the ability to see and access the spine easily. This
type of surgery, however, involves long incisions, cutting and removal of muscle from the spine, and
considerable post‐surgical pain. Due to the large incisions and significant damage to the muscle, open
surgery patients may experience long hospital stays, long recovery periods, large scarring and pain that make
this type of surgery daunting and exhaustive. Developing procedures that significantly reduce these effects
through minimally invasive methods may allow patients to return to regular, active lives with less
interruption and pain.
Minimal invasive spine (MIS) procedures allow the surgeon to perform conventional and advanced spine
surgery techniques through a small incision, with minimally disruptive effects on surrounding tissues and
muscles, producing results that exceed by far the traditional open approaches.
The incision is usually 1/10 the size of the underlying mass. The minimally disruptive microsurgery
procedures we perform are usually on “a day surgery” basis (same day release) and certainly always with the
shortest hospitalization time possible. They result in less operative trauma, less pain and scarring, no loss of
blood, reduces the incidence of post surgical complications and speeds up recovery.
Which are the Minimally Invasive Surgery Benefits?
Small incisions
Minimal surgical scars
Little or no blood loss
Reduced trauma to the body
Less post‐operative pain
Fewer complications
Shorter hospitalization, Faster return to daily activities
Quicker recovery time
Reduced risk of infections
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2. American Institute of Minimally Invasive Spine Surgery
Procedures AIMIS surgeons perform
ALIF: Anterior Lumbar interbody fusion
Anterior cervical corpectomy
Anterior cervical discectomy & fusion
Artificial cervical disc replacement
AxiaLIF (Axial Lumbar Interbody Fusion)
Dekompressor Discectomy
Kyphoplasty
Laminectomy
Lumbar disk microsurgery
Lumbar Interbody fusion
PLIF: Posterior Lumbar interbody fusion
Posterior cervical foraminotomy
TLIF: Transforaminal Lumbar interbody fusion
Total disc replacement
XLIF Lumbar Corpectomy
XLIF: Lateral Lumbar interbody fusion
The field of minimally invasive spine surgery continues to grow, and most conditions today can be treated
with some form of minimally invasive surgery.
Maximum Access Spinal Technologies
Minimally invasive procedures made possible by Maximum Access Spinal
Technologies (MAST) potentially allow surgeons to successfully treat back pain and
deformity with the least amount of interruption while achieving the same surgical
objectives as open surgeries. These technologies have been developed out of the
advances made in the field of orthopedic minimal access surgeries over the past
two decades. Video cameras, x‐rays, detailed anatomy imaging, computer‐assisted
navigation, specially designed instruments and precise diagnostic tools provide
alternatives to conventional open spine surgery that may minimize patient recovery time and pain.
MAST procedures mean surgeons may achieve the same results and objectives of traditional surgery with
imaging systems, tiny cameras and skin incisions no longer than thumbnails. Muscle is left intact and only
separated, or “split,” along natural divisions to reach the affected area. Special live‐action x‐ray machines
guide surgeons to exact locations on the spine, rendering moot any need to open the site for clear
visualization and location of the spinal problem. MAST products provide surgeons the ability to work
precisely in smaller surgical fields with significantly less tissue trauma.
AIMIS Spine P.O. Box 52252, CY-4062 Lemesos, Cyprus
T: +357 77 777995, F: +357 25 320370, email: info@aimisspine.com
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3. American Institute of Minimally Invasive Spine Surgery
The potential patient benefits of MAST procedures can offer patients physical, psychological, emotional and
aesthetic advantages that make surgery less daunting.
Clinical Experience
Maximum Access Spinal Technologies are part of a new minimally invasive area in spine surgery. However,
studies for MAST procedures indicate very high levels of patient satisfaction, shorter recovery periods and
minimal post‐operative pain. While the results have been promising, the full benefits and superiority of
MAST procedures over traditional open surgeries have not been established.
What Is Lateral Access?
Lateral access is a minimally disruptive approach to the spine from the side of the body. With sophisticated
nerve avoidance technology, the surgeon approaches the spine through a small incision or two on the
patient's side, avoiding the abdominal incision of traditional anterior approaches, and the dissection or
retraction of the sensitive back muscles, typical of traditional posterior approaches. The lateral approach
minimizes or avoids the risk of potential complications such as vascular injury, major bleeding, intestinal
injury, ureteral injury, sexual dysfunction, and postoperative back muscle pain.
The NuVasive® NeuroVision JJB Nerve Monitoring System
The NuVasive® NeuroVision JJB Nerve Monitoring
System is a technologically advanced EMG system that
assists your surgeon with safe implant placement and
surgical technique by monitoring your nerve activity
throughout the surgical procedure. EMG stands for
electromyography, which is the study of the electrical
activity of muscles. It can be used during surgery to
determine the health and function of nerves, particularly
in cervical or lumbar spine surgeries where nerve roots
are affected.
NeuroVision combines intraoperative electrically
stimulated EMG and spontaneous EMG activity to assess
possible nerve root irritation or injury during spine
surgery. Patent‐pending software algorithms help
provide the surgeon with real‐time data to assist with patient nerve safety. Monitoring the muscles requires
the placement of adhesive electrodes on the skin overlying your leg muscles (for lumbar surgery) or your
AIMIS Spine P.O. Box 52252, CY-4062 Lemesos, Cyprus
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4. American Institute of Minimally Invasive Spine Surgery
arm muscles (for cervical surgery). These electrodes will record muscle activity during the procedure,
providing information about the health and function of the specific spinal nerves that provide muscle activity
and sensation functions to them.
NeuroVision® Value
Surgeon‐Controlled Nerve & Spinal Cord Monitoring
• Direct, objective, real‐time feedback
• Enhances clinical decision making
• Easy to use, seamless procedure integration
• Intraoperative verification of pedicle integrity and nerve root safety
• Helps Ensure Screw Placement Within Pedicle
• Increases surgeon confidence
• Tissue navigation and nerve avoidance
• Reduces fluoro exposure
• Reduces OR time
Protection of the spinal cord
Enables Maximum Access
Provides Documentation of Monitoring Results
XLIF® procedure ‐ Creative and Innovative Spine Technology
By accessing the spine from the side of the body, XLIF eliminates the debilitating effects of cutting back
muscles, removing bone, and retracting the neural elements that are typically experienced after a
conventional posterior surgical approach (PLIF). Additionally, XLIF avoids retraction of internal organs and
major blood vessels as is necessary in the conventional anterior surgical approach (ALIF) to reach the spine.
XLIF is a safe and reproducible approach with minimal disruption, making post‐op recovery easier for the
patient.
The XLIF procedure for lumbar fusion was developed to overcome the obstacles of both anterior (front) and
posterior (back) approaches to access the spine. XLIF avoids significant musculature disruption by utilizing a
natural path from the side of the body to the spine. This is called “lateral access.” The highly
integrated MAS® System provides significant benefits to patients, including reduced surgery time, less blood
loss, shorter hospital stays, and significantly faster recovery time.
The XLIF approach does not require back muscle and bone dissection or nerve retraction; it also allows for a
more complete disc removal and predictable implant insertion, compared with traditional posterior
procedures. XLIF also does not require the delicate abdominal exposure or present the same risk of vascular
injury as traditional anterior procedures.
Because the procedure is less disruptive than conventional posterior or anterior surgery, most patients are
able to get up and walk around within a day of the surgery. In general, XLIF surgery results in faster recovery
and return to normal activities.
AIMIS Spine P.O. Box 52252, CY-4062 Lemesos, Cyprus
T: +357 77 777995, F: +357 25 320370, email: info@aimisspine.com
www.AIMISspine.com
5. American Institute of Minimally Invasive Spine Surgery
The less‐disruptive lateral approach is a breakthrough for spine patients, but it is of particular benefit for
active patients who want to return to their active lifestyles more quickly and easily, or those who cannot
tolerate a larger, open procedure because of the increased risks of longer anesthesia time, greater blood
loss, longer hospitalization, and longer recovery.
Potential patient benefits of MAST procedures:
• Quicker return to normal activities
• Less post‐operative pain
• Less damage to muscle and skin
• Easier rehabilitation
• Smaller scars
• Less blood loss
• Outpatient surgery for some patients
Hospital Stay ‐ 1‐2 days with XLIF. 3‐5 days with traditional surgery.
Walking ‐ Same day with XLIF. 2‐4 days with traditional surgery.
Return to Normal Activities ‐ 4‐6 weeks with XLIF. 6 months or longer with traditional surgery.
AIMIS Spine P.O. Box 52252, CY-4062 Lemesos, Cyprus
T: +357 77 777995, F: +357 25 320370, email: info@aimisspine.com
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6. American Institute of Minimally Invasive Spine Surgery
Blood Loss ‐ Less than 100cc with XLIF. 300‐600cc with traditional surgery.
The XLIF® minimally disruptive procedure can be performed for a number of situations. The list below
contains representative examples. The list is not intended to include all possible indications and/or
contraindications.
Any thoracolumbar case above L5‐S1 requiring access to the disc space and/or vertebral bodies. Examples
include:
• DDD with Instability
• Recurrent Disc Herniation
• Degenerative Spondylolisthesis (≤ grade 2)
• Degenerative Scoliosis
• Pseudarthrosis
• Discitis, Vertebral Osteomyelitis (without active infection)
• TDR Revision
• Post‐Laminectomy Instability
• Junctional Disease
Any generally accepted contraindication to fusion, such as:
• Systemic infection
• Osteoporosis
• Significant co‐morbidities
• L5‐S1
• Lumbar deformities with > 30° rotation
• Degenerative spondylolisthesis > grade 3
• Bilateral retroperitoneal scarring (e.g., abscess or prior surgery)
• Need for direct posterior decompression through same approach
(Second posterior micro‐decompression not contraindicated)
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7. American Institute of Minimally Invasive Spine Surgery
Clinical Validation Demonstrating Safety and Reproducibility
Comparison of cost and clinical outcomes for one and two‐level open exposure ALIF and minimally invasive
XLIF 202 patients (87 ALIF, 115 XLIF)
• OR Time: 38% decrease
• Blood Loss: 73% decrease
• Hospital Stay: 55.6% decrease
• Complications: 16.7% (ALIF) v 8.2% (XLIF): 50.1% decrease
OR Time (minutes) EBL (cc) LOS (hours)
200 186.4 400 125
353.8
150.6 100 95.9
150 300
121.8 241.7
71.9
75
100 93.4 200 ALIF
50 42.6 XLIF
36.3
95.6
50 100 79.1
25
0 0 0
1‐lvl 2‐lvl 1‐lvl 2‐lvl 1‐lvl 2‐lvl
• XLIF is the only lateral approach procedure validated by nearly a decade of clinical experience.
®
• Documented safety with excellent clinical outcomes.
• XLIF is the only lateral approach procedure validated by nearly a decade of clinical experience.
• Documented safety with excellent clinical outcomes.
• When compared to traditional fusions, XLIF has demonstrated reduced blood loss, less O.R. time,
and shorter hospital stay.
Surgeon:
• Improved patient care
• Increased O.R. efficiency (from 3 hrs. down to less than 1 hr.)
• Less time making rounds
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T: +357 77 777995, F: +357 25 320370, email: info@aimisspine.com
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8. American Institute of Minimally Invasive Spine Surgery
Patient:
• Shorter hospital stay (discharged same day or after 1 night, vs. 3‐4 days)
• Faster return to normal activities (4‐6 weeks vs. 12 weeks)
Hospital:
• Reduced total cost of procedure (savings of ~10%) *
*Deluzio KJ, Lucio JC, Rodgers WB. SAS Journal 4:37-40, 2010.traditional fusions, XLIF has demonstrated reduced
blood loss, less O.R. time, and shorter hospital stay.
XLIF & SCOLIOSIS
Adult degenerative scoliosis is a complex pathology usually requiring a complex solution. In the growing era
of minimally‐invasive surgery, more and more patients are presenting to surgeons requesting these
techniques. The “90‐degree” or extreme lateral interbody fusion (XLIF) technique has been developed for
treating various etiologies of spondylosis. One must take into consideration a patient’s presenting
complaints and comorbidities.
XLIF may be the first step in a staged plan to correct adult degenerative scoliosis.
XLIF CORPECTOMY
Since its inception, XLIF adoption has grown significantly and the
indications continue to evolve and expand. XLIF has changed the
way many look at treatment options for the spine by enabling
surgeons to efficiently perform conventional surgery with
minimal trauma to the patient. Initially, the procedure was used
to primarily treat single‐level degenerative disc disease in the
lumbar spine. As surgeons realized the capabilities and efficacy of
the XLIF technique, its indications quickly expanded toward more
advanced applications, including multi‐level disease, adjacent‐level disease, degenerative scoliosis, revision
surgeries, thoracic applications, and more.
Traditionally, the surgical options for addressing tumor and trauma spine pathologies anteriorly involve
excessive exposures that result in high patient morbidity and limit the treatment population. Now with the
XLIF Corpectomy technique, surgeons are able to treat tumor, trauma, and infection conditions through a
safe and reproducible approach that utilizes conventional instruments and direct visualization. XLIF
Corpectomy offers the most direct access to the pathology and an optimal exposure for spinal cord
decompression. While the surgical goals are achieved with XLIF Corpectomy, the exposure‐related morbidity
is greatly reduced and patients recover faster.
XLIF Corpectomy is a seamlessly integrated system from start to finish. The MaXcess® III Access System,
NeuroVision® intraoperative monitoring, X‐CORETM Expandable VBR, multiple fixation options, and biologics
are combined to provide a safe and reproducible solution for anterior column reconstruction with minimal
exposure‐related morbidity.
AIMIS Spine P.O. Box 52252, CY-4062 Lemesos, Cyprus
T: +357 77 777995, F: +357 25 320370, email: info@aimisspine.com
www.AIMISspine.com
9. American Institute of Minimally Invasive Spine Surgery
Minimally Disruptive Motion Preservation For The Lumbar Spine
XL TDR® ‐ Introducing a new surgical solution
Unlike other total disc replacement devices, that require an anterior
abdominal approach that can be technically demanding, especially at
the L4–5 level, because the great vessels must be mobilized to achieve
optimal exposure and device placement.
XL TDR® is a total disc replacement that is implanted from the patient's
side, an approach which radically improves the patient experience. XL
TDR is building on the success of XLIF, ® the lateral approach spine
fusion procedure introduced by has been successful in treating
thousands of patients suffering from a variety of spinal disorders.
XL TDR seeks to relieve the painful symptoms associated with lumbar
degenerative disc disease. However, instead of achieving pain relief through fusion (immobilization of the
spinal segment), XL TDR seeks to relieve pain while restoring height and maintaining motion at the spinal
segment. Through thoughtful and careful scientific study, we seek to demonstrate the safety and efficacy of
this device, compared to other fusion procedures.
Transforaminal Lumbar Interbody Fusion
The NuVasive® MAS (Maximum Access Surgery) TLIF procedure is a
minimally invasive approach to traditional back surgery.
In a MAS TLIF, rather than starting from the center and spreading the
muscles outward, the surgical approach starts at an angle to the spine and
bluntly splits (rather than cuts) back muscles on just one side. This procedure
attempts to reduce the approach‐related muscle pain often seen in
traditional back surgeries by minimizing the amount of muscle tissue
disruption.
The surgery offers the same advantages as traditional TLIF, but with the
added benefit of less tissue disruption and therefore less postoperative pain
and quicker recovery.
SPHERX DBRII®
SpheRx DBR II is designed to enable the surgeon to dictate how each surgery is performed.
Offering two patented rod designs, delivered through four insertion techniques, SpheRx DBR II provides an
unprecedented ability for the surgeon to customize the approach to the individual patient and procedure. In
addition to remarkable versatility, SpheRx DBR II is designed to be incredibly efficient with an advanced
locking Guide design, seamless reduction capabilities, and exclusive “instrument‐free” compression. SpheRx
DBR II delivers a combination of versatility and efficiency which has previously eluded minimally disruptive
pedicle screw fixation.
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10. American Institute of Minimally Invasive Spine Surgery
The key feature to SpheRx DBR is NuVasive's patented* dual ball rod. It should be positioned as the ideal
posterior fixation system as an adjunct to XLIFs, MaXcess TLIFs, ALIFs and other minimally disruptive
procedures requiring supplemental posterior fixation.
The following are among the most significant benefits of the SpheRx DBR system.
• Simple, constrained rod insertion
• Greatly simplifies the process of inserting the rod into the screws in a minimally disruptive fashion.
• Eliminates the need to interpret whethera rod is properly seated into the screw heads.
• An unmatched ability to apply virtually "instrument‐free" compression
• Effective compression (up to 5mm) can be applied without the need for additional bulky and/or
awkward instrumentation.
• “Zero Profile" rod overhang
• Minimizes the potential for potentially problematic hardware profile and greatly reduces the
likelihood of superior facet joint violation.
The AxiaLIF® Procedure
AxiaLIF stands for Axial Lumbar Interbody Fusion ‐ a new, alternative
approach to traditional fusion procedures.
The surgeon accesses the low back through a 1‐inch incision next to the
tailbone.
The procedure is minimally invasive, so the scars are very small and the
procedure carries less risks than a traditional “open” surgery.
AxiaLIF does not cut through important tissue or nerves
The healing process is quicker and there is less post‐operative pain
commonly associated with traditional fusion surgery.
The AxiaLIF procedure time is typically 45 minutes and patients have been
released from the hospital in as little as 24 hours, returning to work in as
little as 15 days.
Sacroiliac (SI) Joint Surgery with iFuse implant system
Sacroiliac joint fixation is a surgical procedure in which the joint is fixed to its intended position and
weightbearing function.
The incidence of SI joint degeneration in post‐lumbar fusion surgery is 75% at 5 years post‐surgery.1
1. Ha, Kee‐Yong et.al Degeneration of sacroiliac joint after instrumented lumbar on lumbosacral fusion. spine,2008; 33(a):1192‐1198
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11. American Institute of Minimally Invasive Spine Surgery
With the iFuse Implant System™, this is accomplished by inserting three small
titanium implants across the joint to fix and stabilize it.
It is a new minimally invasive lateral surgical approach to the management of SI
joint disruption and dysfunction. SI‐Fuse provides immediate post operation SI joint
stability, it is biomechanically superior to the conventional surgical fixation with
minimal blood loss and one day hospital stay.
Both the surgical technique and the iFuse Implant System are designed to offer the
maximum protection to your surrounding tissues and minimize soft tissue exposure.
SI‐Fuse provides immediate post operation SI joint stability, it is biomechanically
superior to the conventional surgical fixation with minimal blood loss and one day
hospital stay.
Product Benefits
• Less invasive than traditional open surgery with no extensive soft tissue stripping
• Straightforward minimally invasive (MIS) surgical approach
• Implant profile and design minimizes rotation and micromotion
• Rigid titanium implants provide immediate post‐op SI joint stability
• Porous plasma spray coating with irregular surface designed to support stable bone fixation/fusion
• Larger implant surface area designed to maximize post‐surgical weight bearing capacity
• Biomechanically rigorous implant designed specifically to stabilize the heavily loaded SI joint
OptiMesh® — Anatomy‐Conserving™ Spine Surgery
The Spineology One‐Pass discectomy system and OptiMesh® 1500E
implant combine to become the world’s most minimally invasive spine
fusion system. Minimal damage to muscle, ligaments and soft tissue
reduces post‐operative pain, length of hospital stay and recovery time.
With the Spineology system, the disc space is accessed with one pass
of a very small tube, allowing discectomy, fusion site preparation, then
insertion and filling of an OptiMesh implant through the One‐Pass
tube. OptiMesh is a porous mesh that is inserted into the disc space
empty, then it conforms to the prepared cavity and endplate irregularities while being filled with bone graft,
resulting in a large, custom‐fit, load‐bearing allograft spacer. The process of inserting bone into the mesh
creates a distraction force that can increase disc height and re‐tension the surrounding structures, restoring
anatomical relationships and providing indirect decompression of affected nerves. The principles of
interbody fusion technique; discectomy, site preparation, and graft placement are all accomplished through
the One‐Pass tube creating the ideal physical and biologic environment for OptiMesh fusion.
AIMIS Spine P.O. Box 52252, CY-4062 Lemesos, Cyprus
T: +357 77 777995, F: +357 25 320370, email: info@aimisspine.com
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12. American Institute of Minimally Invasive Spine Surgery
Regenerative Technologies ‐ Autologous, point‐of‐care, regenerative cell therapies
We recognize the potential benefits of tissue regeneration as a
solution to overcome the challenges of healing after
surgery. Research indicates that regenerative cell technologies for
orthopedics and spinal procedures are a reality today. SpineSmith®
is collaborating with biomedical engineers, surgeons and scientists
to develop a product offering that is intended to complement
innovative spine devices and positively influence the desired
outcomes of spinal surgeries.
The ART 21, Autologous Regenerative Therapies of the 21st century,
is a biologics system designed to concentrate a patient's own adult
stem and regenerative cells to be used to help facilitate the body's
capacity to heal itself. Delivering a highly concentrated amount of
the patient's own stem cells promotes the natural healing and regeneration of tissues. The ART21
concentrates adult stem, progenitor, endothelial, and platelet cells from a sample of the patient's bone
marrow. It is done within minutes through a simple surgical technique with only mild discomfort to the
patient. The extracted adult stem cells are then implanted back into the patient. The entire procedure is
done at point‐of‐care, meaning the cells are returned to the patient during a single session and are not
exposed to potentially dangerous cell culture or cryopreservation reagents.
Current Applications for Regenerative Cell Products:
Autologous, point‐of‐care, regenerative cell therapies from multiple tissue sources
Cell concentration and delivery technologies
Novel Scaffolds and Substrates for guided tissue regeneration
AIMIS SPINE member surgeons
Due to the vast experience of AIMIS Spine member surgeons and the advanced technology they use, the
risks specific to any spinal surgery which we summarize below are minimized.
Revision or reoperation, change in lordosis, injuries to kidneys or ureters, deterioration in neurological
status, facet joint deterioration, spondylolysis, spondylosis, spondylolisthesis, nerve damage due to surgical
trauma, neurological difficulties including bowel and/or bladder dysfunction, retrograde ejaculation,
tethering of nerves in scar tissue, muscle weakness or paresthesia, vascular damage including hematoma,
ileus injuries, deep vein thrombosis potentially leading to pulmonary embolism, catastrophic or fatal
bleeding, dural tears experienced during surgery resulting in the need for further surgery for dural repair, a
chronic CSF leak or fistula, and possible meningitis, bursitis, paralysis, damage to lymphatic vessels and/or
lymphatic fluid exudation, fracture of bony structures, anesthetic reaction, bowel perforation, hernia,
infection‐peritonitis, peritoneal adhesions, failure of the procedure to improve symptoms and/or functions,
spinal stenosis, and death.
AIMIS Spine P.O. Box 52252, CY-4062 Lemesos, Cyprus
T: +357 77 777995, F: +357 25 320370, email: info@aimisspine.com
www.AIMISspine.com