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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 treatments 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 treatments.

2. Approved pain treatments are contraindicated, have caused or

intend to cause adverse effects specific to individual patients.

3. Drugs or drug based injection treatments 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

treatments to multiple areas or require frequent repetitive

treatments.

5. Patient’s best interests are served by an individualized and

customized plan of pain treatment formulated by the treating

pain physician.

(2)

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 treatment

.

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 treatments 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 treatments.

Immediate Resolution Of Pain Symptoms

Immediate Improvement In Function

Long Lasting Pain Relief

No Drugs, No Anesthetics, No Adverse Effects

For More Info

Call 310-601-7635

Or Visit: www.inter-pain.com

Advanced

Interventional

Pain Center

Precise Diagnosis*Better Outcomes

11645 Wilshire Boulevard, Suite 852

Los Angeles, CA 90025

(3)

The Future of Pain Care is Here!

DT-LILT™ and LILA® are pending FDA approval

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.

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 treatments for focal pain conditions. LILA® does not require any drugs and no sedation is required for the procedure. LILA® is devoid 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 treatments in their office with very little training.

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.

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.

DT-LILT™ is devoid of adverse effects when used

appropriately and for this reason can be safely performed in a physician’s office.

(4)

DT-LILT™ and LILA® are pending FDA approval

Table 1.

Pain Condition

Treated Area of Laser Anatomical Application Neuroablation of C Fibers of nerve or nerve branch DRE % Relief from Chronic Pain at 8 weeks* Post procedure tactile, sensory, motor functions Facet Joint

Arthritis Facet Joints (any level) Medial branch nerves 100% in the 1

st

treatment No change

Sacro-iliac

Arthritis Sacro-iliac joints L5, S1, S2 100% in the 1

st

treatment No change

Occipital

Headache Sub-Occipital Area of Cranium Occipital Nerve, (C-2) 95% in the 1

st

treatment, 100% after the 2nd

No change

Shoulder DJD Shoulder Joints Supra-scapular

nerve, (C-4) 100% in the 1

st

treatment No change

Knee DJD Knee Joints Femoral, tibial

and peroneal (L4, L5)

100% in the 1st

treatment No change

Elbow DJD Elbow Joints Peripheral

Branch of Median nerve

100% in the 1st

treatment No Change

Wrist DJD Wrist Joints Peripheral

Branch of Radial Nerve

100% in the 1st

treatment No change

Trochanteric

Bursitis Greater trochanter S1, L5, L4 100% in the 1

st treatment No change Rheumatic disorders affecting skin with excruciating pain symptoms

Skin All dermatomes 50% relief with

the 1st treatment,

85% relief at 4 weeks after the 2nd treatment No change Rheumatic Disorder affecting large joints Lumbar facets, SI joints and greater trochanter Lumbar medial branch nerves, sacral para-vertebral nerves (L4, L5, S1, S2) 70% relief after the 1st treatment. 100% relief after 2nd, 4 weeks later at follow up No change

*Diagnosis related estimated pain relief

Instantaneous pain relief with LILA® has been

observed in hip and ankle pain after LILA® treatments. Single session whole body treatment 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 treatments 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 treatments in personnel of armed forces, law enforcement, operators of public transport and heavy machinery : LILA® should be the first choice of treatment in this group being a drugless pain treatment modality, avoiding sedation and drowsiness.

Instantaneous and sustained pain relief can be obtained with LILA® where indicated resulting in early return to work.

(5)

The Future of Pain Care is Here!

DT-LILT™ and LILA® are pending FDA approval

Theoretical Considerations where LILA® may be effective are listed below. Physician researchers interested in using LILA® for the following should contact Dr. Srinivasan at 765-891-0721 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 treatments 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 treatment, 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 treatment 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

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

The origin of radicular pain is at the spinal neuroforamen or within the spinal canal and these areas are an absolute contraindication for LILA®.

(6)

DT-LILT™ and LILA® are pending FDA approval

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: 765-891-0721

E-mail: srinidoc@inter-pain.com www.inter-pain.com

LILA® laser treatments 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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