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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 
 

 

 
 


                                                                    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
                                                                                                                         
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
                                                                                                   www.AIMISspine.com
                                                                                                                       
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
                                                      T: +357 77 777995, F: +357 25 320370, email: info@aimisspine.com
                                                                                                  www.AIMISspine.com
                                                                                                                      
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
                                                                                                                       
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
                                                                                                    www.AIMISspine.com
                                                                                                                        
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) 
 

 

 

 


                                                                  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
                                                                                                                       
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 

 

 


                                                                        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
                                                                                                                             
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
                                                                                                                                    
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.  


 


                                                                  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
                                                                                                                       
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  
 


 


                                                                            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
                                                                                                                                     
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
                                                                                                   www.AIMISspine.com
                                                                                                                       
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
                                                                                                                       

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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          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  
  • 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 www.AIMISspine.com  
  • 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 T: +357 77 777995, F: +357 25 320370, email: info@aimisspine.com www.AIMISspine.com  
  • 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 www.AIMISspine.com  
  • 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)          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  
  • 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      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  
  • 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.     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  
  • 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       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  
  • 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 www.AIMISspine.com  
  • 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