Laser Treatment Policy

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1 Laser Treatment Policy Pursuant to federal law 21 CFR 812.2(c)7 and 812.3(b), physician(s) at this pain center may advise and use unapproved laser s on patients under one or more of the following conditions: 1. A pain condition that has consistently failed to improve with approved modalities of pain s. 2. Approved pain s are contraindicated, have caused or intend to cause adverse effects specific to individual patients. 3. Drugs or drug based injection s are contraindicated to an allergic reaction specific to individual patients. 4. Drug based injections may exceed safe dosage standards or may result in adverse effects due to a pain condition requiring s to multiple areas or require frequent repetitive s. 5. Patient s best interests are served by an individualized and customized plan of pain formulated by the treating pain physician.

2 Introducing LILA Low Intensity Laser Ablation Painless Ablation Of Pain Nerves Produces Long Lasting Pain Relief Minimally invasive first in the world non heat producing laser. Selectively targets pain nerves without damaging healthy tissues by a process called LILA or Low Intensity Laser Ablation. Surgery and pain medications can be avoided with long lasting pain relief. The first patient treated in December 2009 is still back pain free. Non cancer bone and joint pain including back pain responds to LILA. Narcotics and similar pain medications are no longer required to manage pain symptoms after. Multiple areas and whole body can be treated at the same time within a few minutes. Get total pain relief in one go! Invented by Dr. Srini, LILA is NOT FDA approved and is available only at Advanced Interventional Pain Center pursuant to federal law 21 CFR 812.2(c)7 and 812.3(b). Patients are selected carefully on a case by case basis. Patients shall bear nominal charges for s and contribute towards data collection and research needed for FDA submission. Individual results will vary. About 100 patients including 10 police officers have been treated with excellent results. Injured workers can expect to get the maximum benefit with these novel laser s. Immediate Resolution Of Pain Symptoms Immediate Improvement In Function Long Lasting Pain Relief No Drugs, No Anesthetics, No Adverse Effects For More Info Call Or Visit: Wilshire Boulevard, Suite 852 Los Angeles, CA Advanced Interventional Pain Center Precise Diagnosis*Better Outcomes

3 Deep Tissue Low Intensity Laser Therapy (DT-LILT ) is a minimally invasive novel technology using Low Intensity Laser Ablation (LILA ) for selectively destroying C pain fibers that are responsible for chronic pain symptoms. A variety of pain conditions that involve C fiber pain transmission can be treated resulting in instantaneous pain relief. Such pain relief is also sustained over several months. DT-LILT indicates the group of medical applications collectively developed for using LILA. Low Intensity Laser Ablation (LILA ) works by employing the phenomenon of cell absorption and self destruction to selectively destroy C pain fibers using a low intensity laser. Heat is not generated in the process preserving the integrity of healthy tissues and other types of nerve fibers. LILA is easy to use, when one or more focal pain conditions exist and are confirmed by a physician s clinical exam and diagnosis. The LILA device is extremely user friendly. Interventional pain physicians should readily be able to use DT-LILT in their office with very little training. of adverse effects when used appropriately and for this reason can be safely performed in a physician s office. Learning LILA and how to apply LILA are easy, as the LILA device is extremely user friendly. Interventional pain physicians should readily be able to use the s in their office with very little training. LILA and DT-LILT are new concepts invented by Dr. Srinivasan, Clinical Director of Advanced Interventional Pain Center. LILA and LILA are in early clinical testing. They offer enormous advantage over all existing modalities of pain s for focal pain conditions. LILA does not require any drugs and no sedation is required for the procedure. LILA is devoid DT-LILT is devoid of adverse effects when used appropriately and for this reason can be safely performed in a physician s office. Table 1. Shows the pain conditions that respond to LILA. Both instantaneous and sustained pain relief are obtained after LILA in these pain conditions. LILA is able to provide pain relief in the focal pain area within a few seconds. Due to lack of adverse effects, multiple areas of pain in one patient can be treated at the same time within a few minutes.

4 Table 1. Pain Condition Treated Anatomical Area of Laser Application Neuroablation of C Fibers of nerve or nerve branch Medial branch nerves DRE % Relief from Chronic Pain at 8 weeks* Facet Joint Arthritis Facet Joints (any level) 100% in the 1 st Sacro-iliac Sacro-iliac joints L5, S1, S2 100% in the 1 st Arthritis Occipital Sub-Occipital Occipital Nerve, 95% in the 1 st Headache Area of Cranium (C-2), 100% after the 2 nd Shoulder DJD Shoulder Joints Supra-scapular 100% in the 1 st nerve, (C-4) Knee DJD Knee Joints Femoral, tibial 100% in the 1 st and peroneal (L4, L5) Elbow DJD Elbow Joints Peripheral 100% in the 1 st Branch of Median nerve Wrist DJD Wrist Joints Peripheral 100% in the 1 st Branch of Radial Nerve Trochanteric Greater S1, L5, L4 100% in the 1 st Bursitis trochanter Rheumatic Skin All dermatomes 50% relief with disorders the 1 st, affecting skin 85% relief at 4 with weeks after the excruciating 2 nd pain symptoms Rheumatic Disorder affecting large joints Lumbar facets, SI joints and greater trochanter *Diagnosis related estimated pain relief Lumbar medial branch nerves, sacral paravertebral nerves (L4, L5, S1, S2) 70% relief after the 1 st. 100% relief after 2 nd, 4 weeks later at follow up Post procedure tactile, sensory, motor functions No Change Instantaneous and sustained pain relief can be obtained with LILA where indicated resulting in early return to work. Instantaneous pain relief with LILA has been observed in hip and ankle pain after LILA s. Single session whole body in multi-joint pain symptoms has also shown to provide both instantaneous and long term pain relief. Rheumatic pain conditions: LILA can effectively reduce pain symptoms of large joints and does not interfere with immunosuppressive s which can be administered concurrently with LILA. Rheumatic patients vary in response to LILA. LILA has been beneficial in SLE related pain symptoms where the RF (rheumatic factor) has been normal. Pain s in personnel of armed forces, law enforcement, operators of public transport and heavy machinery : LILA should be the first choice of in this group being a drugless pain modality, avoiding sedation and drowsiness.

5 Theoretical Considerations where LILA may be effective are listed below. Physician researchers interested in using LILA for the following should contact Dr. Srinivasan at for further information. 1. Sympathetically mediated pain in cancer pain (not tested) : LILA can be employed for prolonged pain relief through C fiber destruction in the thoracic area. We expect LILA to be effective in non metastatic abdominal pain from pancreatic cancer either individually or as an adjunct therapy. These procedures are in development. C pain fiber destruction in the sympathetic trunk is not advisable in non cancer pain using LILA. 2. Temporomandibular Joint Disorder (TMJ) (not tested): LILA can effectively treat TMJ. The procedure is being developed. The facial nerve runs in close proximity to TMJ, for this reason physicians intending to treat TMJ should not use LILA until research results are available. 3. Pediatric pain (not tested): LILA should effectively address C fiber pain transmission during trauma pain by both reducing the sensitivity and intensity of trauma pain in the pediatric population. Procedures are yet to be developed. Research enquiries are welcome. Special Considerations: LILA can provide pain relief where other s have failed or are providing only partial pain relief: 1. Failed back surgery syndrome (FBSS) : Complete resolution of back pain symptoms can be obtained in cases of FBSS with or without posterior fixation rods when facet joints are the cause of pain. About 20 seconds of LILA can provide instantaneous pain relief at L4 and L5 levels in a single, pain relief is sustained over several months. 2. Failed or partial spinal cord stimulation: LILA can augment pain relief when an implanted spinal cord stimulator has failed or is providing only partial pain relief. Spinal cord stimulation should be stopped during LILA and can be resumed after the if needed. 3. Failed or partially effective intrathecal drug pumps: LILA can augment pain relief when an implanted intrathecal drug pump has failed or is providing only partial pain relief. LILA can be applied without stopping the intrathecal pump. Care must be taken not to introduce the laser needle The origin of radicular pain is at the spinal neuroforamen or within the spinal canal and these areas are an absolute contraindication for LILA. into the intrathecal catheter. Intra-operative fluoroscopy is a must for all spinal procedures involving LILA. Absolute Contraindication for LILA : LILA should not be used to treat radicular pain symptoms which are characterized by sharp shooting, non-localizing, radiating pain symptoms as a result of A- delta pain transmission. The origin of radicular pain is at the spinal neuroforamen or within the spinal canal and these areas are an absolute contraindication for LILA. Relative contraindications for LILA : LILA should not be applied in the axilla, cubital tunnel, carpal tunnel, or laterally over the digital nerves. Hip joints are relatively contraindicated using the posterior

6 approach due to the sciatic nerve overlying the hip joints in this area. Other relatively contraindicated areas include the popliteal fossa, tarsal tunnel and digital nerves of the foot. About 100 PATIENTS INCLUDING 10 POLICE OFFICERS HAVE BEEN TREATED WITH LILA WITH OUTSTANDING PAIN RELIEF AND SUSTAINED IMPROVEMENT IN FUNCTION. THERE ARE NO ADVERSE EFFECTS ASSOCIATED WITH LILA For Enquiries in US, contact: Pattanam Srinivasan, M.D. Clinical Director Advanced Interventional Pain Center Tel: LILA laser s are NOT FDA approved and are available only at Advanced Interventional Pain Center consistent with federal law 21 CFR 812.2(c)7 and 812.3(b)

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