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Reduction of Radiation Exposure in Pain Management Applications With MINRAD’s Image Guidance System Florian Geiger, M.D. Consultant for Spinal Surgery University of Frankfurt Department of Orthopedic and Trauma Surgery Frankfurt, Germany Alan R. Brewer, D.D.S., M.D. Director, Interventional Pain Program University of Colorado Health Sciences Center Denver, Colorado

MKT-301117-A Radiation Reduction Doctor Authored Brochure

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Page 1: MKT-301117-A Radiation Reduction Doctor Authored Brochure

Reduction of Radiation Exposure in Pain Management Applications With MINRAD’s Image Guidance System

Florian Geiger, M.D.Consultant for Spinal Surgery

University of Frankfurt Department of Orthopedic and Trauma Surgery

Frankfurt, Germany

Alan R. Brewer, D.D.S., M.D.Director, Interventional Pain Program

University of Colorado Health Sciences CenterDenver, Colorado

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Florian Geiger, M.D.Florian Geiger, M.D. is Consultant of the Department for Spinal Surgery in the Orthopedic Clinic at the University of Frankfurt, Germany. After studying in Homburg and Vienna, with rotations in Bozen, Italy, and New Orleans, LA, he worked at the Balgrist Orthopedic University Hospital in Zurich, Switzerland.

Dr. Geiger then began his residency at the Orthopedic University Hospital in Heidelberg in the department for Rheumatology. After residencies in surgery and traumatology at the University of Mainz, he returned to Heidelberg where he eventually served as Consultant in the Department for Spinal Surgery and Pediatric Orthopedics, prior to moving to Frankfurt in 2006.

He has participated extensively in orthopedic and pain research, co-publishing an extensive array of studies and papers in the Journal of Bone and Mineral Research, European Spine Journal, International Orthopedics, the Archives of Orthopaedic and Trauma Surgery, among many other publications. Additionally, he was a representative of the German Orthopedic Society for the “National Guidelines for the Treatment of Postoperative Pain.”

Alan R. Brewer, D.D.S., M.D.Alan R. Brewer, D.D.S., M.D. has served as the Director of the Interventional Pain Program in the Department of Anesthesiology at the University of Colorado Health Sciences Center since 2001. During this time, he also spent one year as a Commander in the 7215th Medical Support Unit of the United States Army at the Soldier Readiness Processing Center

in Fort Bliss, TX. His military duties took him to Kuwait for five months during 2002.

Dr. Brewer was one of the first pain physicians to perform a clinical study on the use of Medtronic’s Peripheral Nerve Stimulation (PNS) system to treat severe facial pain.

He has extensive experience as an anesthesiologist and in pain management in private practice and as Director of the Pain and Spasticity Management Center at Weseley Rehabilitation Center in Wichita, KS.

His research experience is extensive, including studies on thalidomide in the treatment of fibromyalgia and neuropathic pain syndromes, botulism toxin and the treatment of migraine headaches and myofascial pain syndromes, and occipital nerve stimulation for the treatment of migraines, among numerous others.

He has published multiple papers in several highly-respected publications, including the Journal of Investigative Surgery, Gastroenterology, and Pharmacotherapy.

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Introduction

Many articles have been written and presented discussing concerns about the amount of radiation

that pain practitioners and related personnel are exposed to daily. Also considered in these studies is the important aspect of accumulated radiation when multiple patients are treated every day over a period of years. The increased use of fluoroscopy has exacerbated this issue.

Studies indicate that 15% to 45% of patients with chronic back pain suffer from facet joint syndrome, including lumbar facet syndrome2, 3 (Fig. 1). Facet joint injections have been found to substantially reduce this pain.5, 6, 9–13

In the U.S., facet joint injection rates increased by 231% between 1994 and 2001.8, 9 Between four and ten million interventional pain procedures are performed in the U.S. each year, with at least half of them involving fluoroscopy.7, 8 It is estimated that with increases in fluoroscopic use, the

Fig. 1: Lumbar spine model and x-ray of the lumbar spine in posterior-anterior and 45°-view. Note the markings of the left facet joints of lumbar vertebra 3 to 5.

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radiation dose received through these procedures is about 10% of total medical exposure.1

Previous studies address fluoroscopically guided injection procedures, along with related pain assessment and pain reduction6, 7, 9–11. However, only a few studies consider radiation-dose data, with the majority of applications in vertebroplasty and pedicle-screw placement. 4, 5, 12, 13 In one study by Manchikanti et al., different radiation exposures in interventional pain management were recorded.12 Here, 352 of 1,000 patients were treated with lumbar facet joint injections. Mean time of radiation exposure was 5.7 seconds with a range of 1–14 seconds. In two subsequent studies by the same researchers, 1,656 evaluated patients experienced radiation exposure times ranging from 4.9 to 7.5 seconds, with all treatments delivered by experienced physicians.5,12,13

Various suggestions have been made for reducing the amount of radiation exposure, including more efficient x-ray machines, use of lead-lined gloves, the wearing of radiation-blocking protective clothing, and the utilization of lead skirts that hang from procedure tables to help block reflective radiation from the bottom of the table.

Now a new option has been developed that utilizes a precision targeting system. This image guidance technology provides laser guidance designed to direct the tip of the needle to the appropriate anatomic position for multiple types of interventional procedures. This technology has the potential to decrease the time of exposure (seconds) and number of fluoroscopic views required, while reducing the amount of radiation exposure (mGy) to physicians, medical personnel, and patients. Additional potential benefits include extending the life of x-ray equipment and permitting the pain practitioner to increase his/her procedural volume without increasing associated, radiation-based risks.

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MINRAD’s Image Guidance System is designed to enhance the safety and efficacy of fluoroscopically guided surgery and interventional procedures. The system’s image guidance technology provides continuous visual confirmation of accurate instrument orientation to assist in targeting the precise desired subcutaneous anatomy.

As the two studies within confirm, this image guidance system can reduce the need for additional fluoroscopic views to confirm instrument placement, thereby decreasing radiation exposure for physicians, medical personnel and patients. In the first study discussed here, the mean exposure time of radiation, when using MINRAD’s Image Guidance System in conjunction with fluoroscopy, was reduced significantly by 32.7%. In the second study, the average reduction in radiation time exposure was 47.5%, with a reduction in radiation of 51% (Table 4).

To quantify and provide an overview of these potential advantages, MINRAD undertook research with two pain management experts, Florian Geiger, M.D., of the University of Frankfurt and Alan R. Brewer, D.D.S., M.D. of the University of Colorado. A report on their research and findings is included in this publication.

Overview of MINRAD’s Image Guidance SystemMINRAD’s SabreSource™ Targeting System is a real-time image guidance system for pain management and other interventional fluoroscopically guided surgical procedures. This system provides an accurate surface point of entry and angle of approach to subsurface targets with an accuracy of ± 1 mm at a distance of 1 meter.

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The SabreSource™ Targeting System provides visible cross hairs on the fluoroscope screen that can be positioned to target the desired subsurface structure (Fig. 2). The SabreSouce™ Targeting System directs a visible laser beam onto the patient, which is precisely aligned with the cross hairs on the fluoroscopic image. This provides the correct point of entry and angle of approach to the desired subsurface target.

Once the desired subsurface structure is centered in the cross hairs, the x-ray source can be turned off while the laser is used as a guide. MINRAD’s Light Sabre™ instruments incorporate a patented light collimating tube that captures the SabreSource™ laser when the instrument is precisely aligned to the targeted structure (Fig. 3). Light Sabre™ instruments have an accuracy of ± 3 mm at a depth of 100 mm.

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Fig. 2: Fluoroscopic image before injection of the right facet joint L4–L5. Note the cross hairs provided by the SabreSource™ Targeting System on the fluoroscope screen that can be positioned to target the desired subsurface structure.

Fig. 3: Note the illumination of the light element on the collimating tube when the point of entry and angle of approach of the Light Sabre™ needle is correct.

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IntroductionThis pilot study was performed to compare and contrast radiation exposure during facet joint injection procedures. Two groups of patients were treated. Fluoroscopy was used to treat the first group of patients, while the second group was treated with the use of MINRAD’s Image Guidance System in conjunction with fluoroscopy.

Materials and MethodologyThis study involved 60 patients. All patients suffered chronic lower back pain for a minimum of six months and had lumbar facet joint syndrome. None of the patients had previously received interventional treatment or undergone operations in the lumbar spine. No participant had experienced radicular neurologic symptoms or coagulation disturbances. No patient in the study had a prior history of rheumatic disease, allergic reactions to local anesthesia, pregnancy, relevant infections, or vertebral fractures.

Age range of study participants was 51 to 69, with a mean age of 60.52 years and a BMI of 26.24. Patients were

Comparative Study Using Radiation Dosage, Radiation-Exposure Time, and Entrance Surface Dose on Interventional Procedures Solely Using Fluoroscopy, and Interventional Procedures Using Image Guidance in Conjunction With Fluoroscopy

Study by Florian Geiger, M.D., University of Frankfurt

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divided into two study groups of 30 (Table 1). Each participant in Group A and Group B received two injections to the facet joints: L4-L5 or L5-S1. Group A received intervention guided by fluoroscopy alone; Group B received intervention guided by MINRAD’s Image Guidance System in conjunction with fluoroscopy. Prior to procedures, the mean VAS (visual analogue scale) in Group A was 8.0 with a range of 7.0 to 10.0; in Group B, the mean VAS was 7.8 with a range of 6.0 to 10.0.

All procedures utilized a single C-Arm with all injections performed from the left side of the patient. Radiation doses were monitored by the fluoroscopic unit equipped with a dosimeter incorporated into the assembly of the x-ray tube head. During and after injections, the number of exposures, active radiation duration, and dose of radiation were measured and recorded.

For the procedures using MINRAD’s Image Guidance System, the SabreSource™ device was mounted on the x-ray source of the C-Arm and secured via an adjustable strap. When installation was completed, the C-Arm was positioned with the x-ray source superior and the image intensifier inferior.

Prior to treatment, the SabreSource™ Targeting System was properly aligned to assure the accuracy of the system (Fig. 4).

Table 1: Demographic data

Total number of patients 60

Male 31

Female 29

Mean age (years) 60.52 (range 51–69)

Mean body mass index 26.24 (range 22.2–29.9)

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Fig. 4: The SabreSource™ Targeting System (1) directs a visible laser beam onto the patient which is precisely aligned with the cross hairs on the fluoroscopic image. (2) Remote control for moving cross hairs and laser during the intervention. (3) Alignment Sabre™ device used for alignment of the system (4) Light Sabre™ needle and collimating tube. (5) Mounting of the SabreSource™ Targeting System onto the fluoroscopy machine.

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Alignment was completed in a mean time of 6.26 minutes, with a range of 4.34 to 8.12 minutes. The mean Entrance Surface Dose (ESD) was 0.4 mGy with a range of 0.25 to 0.65 mGy. At least six patients were treated per session to avoid the need to repeat a general alignment procedure for each patient. Radiation exposure as a result of the SabreSource™ alignment procedure is minimal.

ResultsIn Group A (fluoroscopically guided intervention), the mean VAS prior to injection therapy was 8.0 with a range of 7.0 to 10.0. A mean VAS of 3.2, a reduction of 60% in pain, was documented four hours following injection therapy. The mean number of exposures was 4.53, with a range of 4.0 to 6.0. Mean radiation-exposure time was 3.46 seconds, with a range of 2.0 to 4.0. Mean ESD was 2.01 mGy, with a range of 1.61 to 2.42 (Table 2).

In Group B (Intervention guided by MINRAD’s Image Guidance System in conjunction with fluoroscopy), the mean VAS prior to injection was 7.8, with a range of 6.0 to 10.0. A mean VAS of 3.0 and a reduction of 61.5% in pain was documented four hours following injection therapy. The mean number of exposures was 3.30, with a range of 3.0 to 4.0. Mean radiation-exposure time was

Table 2: Illustration of demographic data and radiation exposures in Group A

Group A: fluoroscopically guided intervention

Number of patients 30

Mean age (years) 60.6

Mean body mass index 26.23 (range 22.2–29.7)

Mean number of fluoroscopic images taken 4.53 (range 4.0–6.0)

Mean time of radiation exposure (seconds) 3.46 (range 2.0–4.0)

Mean ESD (mGy) 2.01 (range 1.61–2.42)

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2.33 seconds, with a range of 1.0 to 3.0. Mean entrance surface dose (ESD) was 1.36 mGy, with a range of 0.91 to 1.58 (Table 3).

Both Groups A and B saw a similar pain reduction: 60% and 61.5% respectively. However, there were significant differences in the number of fluoroscopy exposures, radiation time exposure, and entrance surface dose (Figs. 5, 6, 7). Group B reflected a significant reduction in exposure to radiation and entrance surface doses.

Radiation exposure mean time was 2.33 seconds in Group B as opposed to 3.46 in Group A. This reflects a significant reduction in fluoroscopy exposure time of 32.7%. The number of fluoroscopy exposures in Group A was 4.53, compared to 3.30 in Group B, reflecting a reduction of 27.2%. Concerning ESD, Group B again showed a meaningful reduction of 32.3%.

In summary, MINRAD’s Image Guidance System used in conjunction with fluoroscopy to perform facet joint injections significantly reduced radiation in the number of fluoroscopy exposures (reduction 27.2%, p = 0.01), the time of radiation exposure (reduction 32.7%, p = 0.01) and the mean entrance surface dose (reduction 32.3%, p = 0.01) when compared to injections done with fluoroscopy guidance alone (Table 2).

Table 3: Illustration of demographic data and radiation exposures in Group B

Group B: Intervention guided by MINRAD’s Image Guidance System in conjunction with fluoroscopy

Number of patients 30

Mean age (years) 60.43

Mean body mass index 26.26 (range 22.3–29.9)

Mean number of fluoroscopic images taken 3.30 (range 3.0–4.0)

Mean time of radiation exposure (seconds) 2.33 (range 1.0–3.0)

Mean ESD (mGy) 1.36 (range 0.91–1.58)

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ConclusionsOn the basis of the clinical test results, as well as results seen in the literature, a radiation dose reduction of at least 20% would be anticipated with use of MINRAD’s Image Guidance System. As noted in this study, actual study results demonstrated a radiation reduction surpassing this estimate.

Considering these results, there was a significant reduction of exposure time and radiation dose compared to facet joint injections performed with fluoroscopy guidance alone. When inserting the Light Sabre™ needle using accurate laser guidance, it is not necessary to activate the fluoroscope. This results in an additional reduction of radiation exposure for the patient and physician alike.

Mean Time of RadiationExposure (sec)

4.03.53.02.52.01.51.00.50.0

Group A3.46 (sec)

Group B2.33 (sec)

Mean Number of Fluoroscopic Images Taken

Group A4.53

Group B3.3

6

5

4

3

2

1

0

Mean ESD (mGy)

Group A 2.01 (mGy)

Group B1.36 (mGy)

2.5

2.0

1.5

1.0

0.5

0.0

Representation of reductions in time of radiation exposure, number of fluoroscopic images taken, and ESD (Entrance Surface Dose) in mGy between Group A (fluoroscopically guided intervention) and Group B (intervention guided by MINRAD’s Image Guidance System in conjunction with fluoroscopy).

Fig. 5 Fig. 6 Fig. 7

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Radiation Dosage Study Comparing Fluoroscopy Utilization With and Without MINRAD’s Image Guidance System

Study by Alan R. Brewer, D.D.S., M.D., University of Colorado Health Sciences Center

IntroductionThis study focused on fluoroscopic intervention in a variety of pain management procedures (facet joint injections and others) and the related exposure times and amounts of radiation delivered. Comparisons were drawn between fluoroscopy delivered in a traditional manner and fluoroscopy treatments utilizing MINRAD’s Image Guidance System.

Materials and MethodologyFourteen patients between the ages of 18 and 65, undergoing bilateral procedures, were involved in this study. MINRAD’s Image Guidance System (as described in the preceding Overview of MINRAD’s Image Guidance System section) was utilized for the interventional fluoroscopically guided procedures discussed here.

Fourteen procedures were performed for this study: three cervical facet injections (Fig. 8), two lumbar facet injections, five lumbar epidural steroid injections, one cervical epidural steroid injection, two SI joint injections and one bilateral gamella muscle injections. All patients were brought to the fluoroscopy suite, positioned appropriately for the specific procedure, and preliminary

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Fig. 8: Cervical Facet Joint Injections.

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films were taken to assure the appropriate levels of the spine were visualized. Equal numbers of injections were performed bilaterally on each patient. MINRAD’s Image Guidance System in conjunction with fluoroscopy was used on one side of the patient while fluoroscopy alone was used on the other side of the patient. Procedures were performed by residents, fellows and staff physicians.

On the side of the patient where MINRAD’s Image Guidance System was utilized, the cross hairs were aligned to the appropriate target. Upon completion of the previous step, the laser appearing on the patient’s skin provided the location for local anesthetic to be applied subcutaneously. The appropriate Light Sabre™ needle was inserted and directed along the path of the laser until the appropriate bone was contacted (facet and SI joint injections), loss of resistance was obtained (epidurals), or the appropriate muscle was entered. Each of the Light Sabre™ needles used provided real-time feedback when the needle was aligned with the laser and on track to hit the desired target. All needle positions were confirmed by injection of contrast material. Finally, medication was injected and the needle was withdrawn.

Both the radiation (mGy) and the time of actual radiation exposure were measured and recorded for each procedure using the data from the C-Arm fluoroscope (Table 4).

Moving to the opposite side of the patient, a similar procedure was performed with fluoroscopy alone. After the appropriate needle was used to puncture the skin, multiple fluoroscopic images were required to ensure the needle was traveling in a straight line to the desired target. The number of additional images averaged from three to seven depending on the size of the patient. Again, both the radiation (mGy) and the time of actual radiation exposure were measured and recorded for each procedure using the data from the C-Arm fluoroscope (Table 4).

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Table 4: X-ray Time and Radiation Exposure

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Procedure Without SabreSource™ With SabreSource™ % Reduction

Time (sec)

Radiation (mGy)

Time (sec)

Radiation (mGy)

Time (%)

Radiation (%)

Cervical facet 17.6 0.945 6.6 0.33 62.5 65

Cervical facet 12 0.89 7.1 0.462 40.8 48.1

Cervical facet 14 0.759 10.5 0.606 25 20.2

CESI 6.8 0.521 3.8 0.285 44.1 45.3

Lumbar facet 7.5 1.539 4.1 0.818 45.3 46.8

Lumbar facet 8.5 0.653 2.5 0.202 70.6 69.1

LESI 6.6 0.788 2.1 0.235 68.1 70.2

LESI 6.7 3.568 3 1.605 55.2 55

LESI 4 0.944 2 0.473 50 49.9

LESI 4 0.506 2 0.229 50 54.7

LESI 10.4 0.938 6.4 0.569 38.5 39.3

SI Joint 15.4 1.944 7.9 0.983 48.7 49.4

SI Joint 7.5 1.2 3.7 0.566 50.7 52.8

Gamella muscle

4.6 0.488 4.3 0.305 6.5 37.5

Total 125.6 15.683 66 7.668

Average 8.97 1.12 4.71 0.55

51% decrease in radiation overall

47.5 % decrease in exposure time overall

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ResultsRadiation exposure times and the amount of radiation required to perform the procedure were recorded and compared with and without the use of MINRAD’s Image Guidance System.

Reductions in radiation exposure (mGy) ranged from 20.2% to 70.2% while reductions in radiation exposure time (sec) ranged from 6.5% to 70.6%. Average reduction in radiation was 51% and reduction in radiation exposure time was 47.5% (Table 4). An equivalent decrease in radiation exposure was seen regardless of who was performing the procedure with the use of MINRAD’s Image Guidance System and Light Sabre™ needles — resident, fellow or staff physician.

ConclusionsMINRAD’s Image Guidance System has been evaluated to help reduce the amount of radiation exposure to both the patient and the practitioner. A 50% reduction in both time and amount of radiation exposure to the individual patient becomes quite significant when evaluating the impact on a practicing physician who may perform 15–20 procedures a day. In combination with protective gloves, clothing and lead shielding, there is now an opportunity to improve quality of life issues and increase patient volume without the worry of increased costs from more expensive radiation shielding techniques. Patients can also be assured that they are receiving the best care with reduced radiation times and exposures, along with the safest techniques.

Based on the results of this study, MINRAD’s Image Guidance System offers reduced radiation exposure, less patient trauma and pain, and increased efficiency and time utilization for both physicians and OR personnel.

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Procedure Without SabreSource™ With SabreSource™ % Reduction

Time (sec)

Radiation (mGy)

Time (sec)

Radiation (mGy)

Time (%)

Radiation (%)

Cervical facet 17.6 0.945 6.6 0.33 62.5 65

Cervical facet 12 0.89 7.1 0.462 40.8 48.1

Cervical facet 14 0.759 10.5 0.606 25 20.2

CESI 6.8 0.521 3.8 0.285 44.1 45.3

Lumbar facet 7.5 1.539 4.1 0.818 45.3 46.8

Lumbar facet 8.5 0.653 2.5 0.202 70.6 69.1

LESI 6.6 0.788 2.1 0.235 68.1 70.2

LESI 6.7 3.568 3 1.605 55.2 55

LESI 4 0.944 2 0.473 50 49.9

LESI 4 0.506 2 0.229 50 54.7

LESI 10.4 0.938 6.4 0.569 38.5 39.3

SI Joint 15.4 1.944 7.9 0.983 48.7 49.4

SI Joint 7.5 1.2 3.7 0.566 50.7 52.8

Gamella muscle

4.6 0.488 4.3 0.305 6.5 37.5

Total 125.6 15.683 66 7.668

Average 8.97 1.12 4.71 0.55

51% decrease in radiation overall

47.5 % decrease in exposure time overall

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Summary

Both studies demonstrate that use of MINRAD’s Image Guidance System during fluoroscopically guided

facet joint injections and other related procedures can reduce the radiation exposure to the patient, physician, and attending personnel. With ongoing concerns about the effects of prolonged, repeated radiation exposure, the degree of radiation reduction with MINRAD’s Image Guidance System is significant.

As MINRAD’s Image Guidance System uses a remote control to direct the cross hairs and laser, a physician can stand at a distance from the fluoroscopic unit and/or behind a protective device during use. This system also provides the point of entry and angle of approach with an accurate visible laser. In using the laser as guidance to hit the desired subcutaneous target, the need for additional fluoroscopic images to maintain the trajectory is mitigated. With this combination of MINRAD’s Image Guidance System and additional protection, it can be postulated that radiation exposure for a physician and related personnel could be reduced to negligible levels. Concurrently, results from both studies also show radiation time and exposure reductions for patients being treated.

Conclusions can also be drawn that a physician and related personnel can save valuable time and consider increasing their volume of fluoroscopic procedures without a significant increase in radiation-related risk.

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References

Geiger Study1. UNSCEAR. Sources and Effects of Ionization

Radiation. UNSCEAR 2000, Report to the General Assembly 2000; Vol. 1.

2. Boswell MV CJ, Sehgal N, Dunbar EE, Epter R. A Systematic Review of Therapeutic Facet Joint Injections in Chronic Spinal Pain. Pain Physician 2007; 10:229-253.

3. Merskey H. Logic, truth and language in concepts of pain. Qual Life Res 1994; 3 Suppl 1:S69-76.

4. Kallmes DF RS, Piccolo RG, Marx WF, Jensen ME. Radiation Dose to the Operator during Vertebroplasty: Prospective Comparison of the Use of 1-cc Syringes versuch an Injection Device. Am J Neuroradiol 2003; 24:1257-1260.

5. Manchikanti L, Cash KA, Moss TL, Pampati V. Effectiveness of protective measures in reducing risk of radiation exposure in interventional pain management: a prospective evaluation. Pain Physician 2003; 6:301-305.

6. Staender M, Maerz U, Tonn JC, Steude U. Computerized tomography-guided kryorhizotomy in 76 patients with lumbar facet joint syndrome. J Neurosurg Spine 2005; 3:444-449.

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7. Zhou Y SN, Abdi S, Wu J, Crawford J, Furgang FA. Fluoroscopy Radiation Safety for Spinal Interventional Pain Procedures in University Teaching Hospitals. Pain Physician 2005; 8:49-53.

8. Friedly F CL, Deyo R. Increase of Lumbosacral Injections in the Medicare Population. Spine 2007; 32:1754-1760.

9. Cohen SP RS. Pathogenesis, Diagnosis and Treatment of Lumbar Facet Joint Pain. Anesthesiology 2007; 106:591-614.

10. Schulte TL, Pietila TA, Heidenreich J, Brock M, Stendel R. Injection therapy of lumbar facet syndrome: a prospective study. Acta Neurochir (Wien) 2006; 148:1165-1172; discussion 1172.

11. Shih C, Lin GY, Yueh KC, Lin JJ. Lumbar zygapophyseal joint injections in patients with chronic lower back pain. J Chin Med Assoc 2005; 68:59-64.

12. Manchikanti L, Cash KA, Moss TL, Pampati V. Radiation exposure to the physician in interventional pain management. Pain Physician 2002; 5:385-393.

13. Manchikanti L, Cash KA, Moss TL, Rivera J, Pampati V. Risk of whole body radiation exposure and protective measures in fluoroscopically guided interventional techniques: a prospective evaluation. BMC Anesthesiol 2003; 3:2.

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Brewer StudyBerlin L. Malpractice issues in radiology: radiation induced skin injuries and fluoroscopy AJR AM J Roentgenol. 2001;178:153-157.

Fishman SM, Smith H, Meleger, A et al. Radiation safety in pain medicine. Reg Anesth Pain Med. 2002;27:296-305.

Norris, TG. Radiation safety in fluoroscopy. Radio Technol. 2002;73:511-533.

Rathmell, JP. Atlas of image guided intervention in regional anesthesia and pain medicine. Sec 1, Ch 2, 9-15.

U.S. Food and Drug Administration. Public Health Advisory: Avoidance of Serious X-ray Induced Skin Injuries to Patients during Fluoroscopically Guided Procedures. Rockville, MD: U.S. Food and Drug Administration, Center for Devices and Radiological Health; September 1994.

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Page 23: MKT-301117-A Radiation Reduction Doctor Authored Brochure

MINRAD Inc. is a developer and manufacturer of

innovative products and technologies sold around the

world for interventional pain management in acute care

settings. MINRAD Inc. has three product lines: (1) anesthesia

and analgesia, (2) real-time image guidance, and (3)

conscious sedation. The anesthesia and analgesia line

consists of manufacturing and selling generic inhalation

anesthetics that are used for human and veterinary

surgical interventions. The real-time image guidance

products consist of the SabreSource™ Targeting System

and accompanying Light Sabre™ disposable instruments.

MINRAD’s Image Guidance products are designed to

improve the accuracy of interventional procedures and

provide a significant reduction in radiation exposure for

both patients and medical professionals. MINRAD Inc. is

also developing a drug/drug delivery system for conscious

sedation, which provides a patient with pain relief without

loss of consciousness.

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© 2008 MINRAD Inc. MINRAD, SabreSource, and Light Sabre are trademarks of MINRAD Inc.

MKT-301117-A (February 2008)

MINRAD Inc. 50 Cobham Drive Orchard Park, NY 14127 USA Tel: (800) 832-3303 (716) 855-1068 Fax: (716) 855-1078www.minrad.comAMEX: BUF

MINRAD EU34, Rue des ChâteauxZ.A. de la Pilaterie 59290WASQUEHAL — France