Medical Policies - Medicine

Electrical Impedance Scanning (EIS) of the Breast


Effective Date:06-15-2018



Electrical impedance scanning (EIS) of the breast is considered experimental, investigational and/or unproven for all indications.


Electrical impedance scanning (EIS) of the breast involves the transmission of continuous electricity into the body using either an electrical patch attached to the arm or a hand-held cylinder. The electrical current travels through the breast where it is then measured at skin level by a probe placed on the breast. Cancerous tissue conducts electricity differently than normal tissue; therefore, cancerous images may show up on the resulting imaging as a bright white spot.

Regulatory Status

The TransScan [T-Scan™] 2000 is an EIS device that received approval for marketing from the U.S. Food and Drug Administration (FDA) in 1999, with the following labeled indication:

“The T-Scan 2000 is intended for use as an adjunct to mammography in patients who have equivocal mammographic finding with ACR (American College of Radiology) BI-RADS™ (Breast Imaging-Reporting Data System) categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy. This device provides the radiologist with additional information to guide a biopsy recommendation.” (1)

The newer T-Scan™ 2000ED (T-Scan ED) was designed to screen younger women (ages 30-39) for breast cancer in the primary setting. (2) The device is fundamentally the same as the T-Scan 2000; however, the post-processing software has been altered to maximize the specificity of the test. It reports a binary (two part) outcome indicating whether or not the woman is at increased risk of cancer at the time of the test (not over her lifetime, not her life-long risk). It does not replace mammography or other imaging tools, but a risk assessment tool. The aim of T-Scan 2000ED is to identify approximately five percent of the target population who may be at five times the risk expected for the age group. It provides a single result for both breasts combined and does not indicate where any questionable lesion is located. A positive result would have to be followed-up by additional breast imaging. This device was reviewed by the FDA’s Obstetrics and Gynecological Devices Panel on August 29, 2006, which recommended unanimously that it not “be approvable.”

Research is underway on combining EIS with mammography or tomosynthesis. (3) The use of EIS to diagnose non-malignant breast disease has also been studied but apparently not with an FDA approved device. The research used a multifrequency electrical impedance tomography device called “MEM” developed at the Russian Academy of Sciences; The MEM device does not appear to be FDA approved. (4)


This policy was originally created in 2005 and has been updated regularly with searches of the Medline database. Most recently, the literature was searched through April 29, 2017. Following is a summary of the key literature to date.

Mammographic abnormalities can be stratified into categories called Breast Imaging-Reporting Data System (BI-RADS) scoring system developed for mammographic evaluation, which reflect the risk of malignancy given the mammographic appearance. Scores range from 0 to 5 as follows (5):

BI-RADS Terminology


Characteristics and Probability of Malignancy


Incomplete, further imaging or information is required, e.g. compression, magnification, special mammographic views, ultrasound. This is also used when requesting previous images not available at the time of reading.


Negative, symmetrical and no masses, architectural disturbances or suspicious calcifications present.


Benign finding (e.g., calcified fibroadenomas, lipoma, simple breast cysts, galactoceles, mixed density hamartomas).


Probably benign finding - Short Follow-up Suggested. The probability of malignancy is estimated at 2%.


Suspicious abnormality; mammographic appearance which is suspicious for malignancy. Biopsy should be considered. The probability of malignancy is 30% in this category.

A score of IV can be further subdivided as:

BIRADS IVa: low level of suspicion for malignancy.

BIRADS IVb: intermediate suspicion for malignancy.

BIRADS IVc: moderate suspicion for malignancy.


Highly suggestive of malignancy – Action should be taken. The probability of malignancy is 95%.


Known biopsy proven malignancy.

The T-Scan 2000 was approved through the Food and Drug Administration (FDA) pre-market approval process, and thus the clinical data to support its safety and effectiveness is available in the FDA summary of safety and effectiveness (1), which is reviewed below. The key pieces of data presented to the FDA were from a multicenter blinded study that intended to test the hypothesis that adjunctive combination of T-Scan with mammography can provide diagnostic accuracy significantly better than mammography alone. The results of this study were reported in terms of sensitivity and specificity instead of positive predictive value (PPV) and negative predictive value (NPV).

The blinded study presented to the FDA consisted of a total of 2,456 patients of whom 882 underwent biopsy and T-Scan. The mammography and T-Scan were performed in a blinded fashion, i.e., each imaging procedure was performed and interpreted without knowledge of the results from any other imaging modality or patient information. A final test set composed of 504 biopsied breasts (179 malignant, 325 benign) was available for re-reading (380 patients were excluded due to unavailability of the original mammogram or incomplete T-Scan image). The test set was re-read and scored “blindly” using T-Scan images alone, using mammograms alone, and using adjunctive combination of mammogram and T-Scan images. Each of the scores was compared against the results of biopsy. Panels of 40–60 patients each were organized for blinded rereading of the T-Scans and mammograms. The panels were composed of patients with both malignant and benign biopsy results, as well as screening patients that did not undergo biopsy. The screening patients were added to the panels so that the readers could not assume that all patients had suspicious mammographic findings. The key subgroup was the 273 patients with equivocal mammographic abnormalities. These included BI-RADS category 3 and some BI-RADS category 4 cases, in which the probability of malignancy was estimated to be between 0 and 50%. Using biopsy results as the gold standard, the sensitivity of the combined mammogram and T-Scan compared to mammogram alone increased from 60% to 82%, while the specificity increased from 41% to 57%. Both are statistically significant increases. However, it is unclear from this study if these diagnostic parameters would enable patients with equivocal mammographic abnormalities to forego biopsy. Recalculating the data reveals that the key parameter of the NPV of the combined test is 93%. Therefore, if the decision to forego biopsy was based on a negative result of the combined mammogram and T-Scan, 7% of those with malignant lesions would miss or delay a diagnosis of breast cancer. (1)

As noted, this study included some BI-RADS category 3 or 4 lesions, but it is not specified whether the biopsies were performed in these subjects as part of the study protocol or based on clinical suspicion and/or imaging results. The analysis of diagnostic performance included only those patients who were scheduled for biopsy, which introduces the potential for verification bias. It is uncertain whether these selected cases would be similar to unselected consecutive cases of BI-RADS category 3 or 4 lesions that would not be referred for biopsy in clinical practice. The PPV of adjunctive use of the T-Scan was reported to be 30% among biopsied subjects with BI-RADS category 3 or 4 lesions and an 18% prevalence of malignancy. However, the limitations and potential bias in this analysis prohibit conclusions regarding the effectiveness of using the T-Scan in positively selecting patients for biopsy. For example, it is unknown how many of the original 2,456 patients had equivocal lesions and decided to forego biopsy. This is the critical group to evaluate the role of the T-Scan to positively select those patients for biopsy who would otherwise forego biopsy. While this unselected population and outcome are admittedly more difficult to study, ideally one would like to design a trial in which all patients with equivocal lesions, which would otherwise be referred for follow-up imaging, undergo both T-Scan and biopsy or some other appropriate reference standard such as prolonged clinical follow-up. In this setting, the diagnostic performance and predictive value of T-Scan could be evaluated in the actual intended use. (1)

The “Intended Use” study presented to the FDA consisted of 74 consecutive biopsy cases in which the T-Scan was approved for clinical use in its full intended mode; i.e., the T-Scan was targeted at lesions previously identified by mammography or physical examination, and the T-Scan interpretation was done adjunctively. Of these, there were a total of 36 cases for which biopsy results, mammograms, and T-Scans were available and where the mammographic results were equivocal. The sensitivity of the mammography alone was 66.7% increasing to 93.3% (28 of 30 cases) when the T-Scan was used adjunctively. The corresponding values of specificity were 50% increasing to 83.3% (five of six cases) when the T-Scan was added. The PPV of adjunctive use of T-Scan was 97% (28 of 29 cases) although the prevalence of malignancy in this subgroup was also very high at 83%. Despite these positive findings, the small number of cases in this study along with the potential bias associated with the fact that analysis was restricted only to half of subjects who received the reference standard makes this evidence insufficient to draw conclusions. (1)

A literature search reveals a variety of case series. Some studies focused on the technical capability of electrical impedance scanning (EIS). (5,6) All the studies that reported on the diagnostic performance of EIS reported an inferior performance compared to that reported in the FDA Summary of Safety and Effectiveness (7-11)

In 2002, Fuchsjaeger and colleagues (12) further explored the adjunctive role of EIS in 121 patients with 128 BI-RADS 4 lesions identified on mammography. Specifically, the results of EIS were compared with ultrasound (US) as a technique of further classifying benign lesions such that patients could be managed as a BI-RADS 3 lesion with a recommended six-month follow-up instead of biopsy. Therefore, in this setting the most relative statistic is the NPV, which can be used to deselect patients from biopsy. Based on histopathology from a subsequent biopsy, there were 37 malignant lesions and 91 benign lesions. The NPV of EIS was 97.1% vs. 92.0% for US. It is unclear whether this diagnostic performance would be adequate to defer biopsy.

Stojadinovic and colleagues explored a novel role for EIS as a primary screening technique in younger women (less than 40 years) at average risk of breast cancer. (13) Currently, there are no specific screening recommendations other than breast self-examination in this population, in part due to decreased sensitivity of mammograms in imaging dense breast, common in younger populations. EIS is based on the difference in electrical conductivity in benign versus malignant tissue and is not impacted by breast density. This study included 1,103 women who were undergoing screening with a clinical breast examination and women who were specifically referred for breast biopsy (the reasons for the referral were not stated). A total of 580 of the women were under 40 years old, the targeted age group for primary screening with EIS. Twenty-nine cancers were identified among the entire group of 1,103; six of these were in women under 40. Based on this small number of cancers, the sensitivity and specificity of EIS in women under 40 was 50% and 90%, respectively. It should also be noted that of the 580 in the under 40 group, 132 (23%) presented with palpable breast lesions, and only two of the six identified cancers were nonpalpable, and all cancers were found in women specifically referred for breast biopsy; none were found in the general screening population. As noted by the authors, this is a preliminary study, and further data with longer follow-up are needed. However, the authors hypothesize that EIS could evolve into a routine part of a physical exam performed in a physician office setting. A positive scan would then prompt further imaging with either a magnetic resonance imaging (MRI) or ultrasound.

In 2006, there appears to be a follow-up study to that of Stojadinovic and colleagues. The results were reported for 1,361 consecutively enrolled asymptomatic women ages 30–39 years (used to measure specificity), and 189 women ages 30–45 years who had a suspicious breast abnormality and were referred for biopsy (used to measure sensitivity). (14) The researchers assumed that none of the women in the first group had breast cancer and, consequently, that any positive EIS results were false positives; no follow-up data were collected on these women. In the second group of women with breast abnormalities, 59.3% were aged 40–45. The specificity in the first group was 95% (assuming all positive results were incorrect); the specificity in the second group among women with benign breast disease was 80.7%. The sensitivity in the second group was 38%, but it ranged from 29% among women aged 30–39 to 42% among women aged 40–45. The authors concluded that the relative probability that a woman with a positive EIS result currently has breast cancer is 7.68 and that about one cancer would be detected for every 77 women referred for follow-up. This study has a number of limitations, including the assumption that none of the women in the specificity arm had cancer (the authors argue that this assumption is likely to have little impact on the overall results given the low prevalence of cancer in this population); the age difference between the two groups (and the difference in sensitivity by age, although whether or not this is statistically significant is not reported), and the measurement of sensitivity and specificity in two different populations. The authors themselves conclude that the results are encouraging but that “further large-scale, long-term follow-up studies are required and underway in the intended use populations.” The FDA’s Obstetrics and Gynecological Devices Panel had several concerns about the study, and the FDA has not approved the device for this use.”

In a later follow-up, Stojadinivoc and co-workers reported on 1,751 patients in the specificity group and 390 patients (with 87 cancers) in the sensitivity group. (15) The patients were recruited at 22 sites in the United States and seven in Israel. The specificity calculated for the first group (assuming all positive test results were incorrect) was 94.7% (95% CI: 93.7–95.7%). One center had a specificity of 84%, while the others ranged from 89% to 97%. Sensitivity calculated for the second group was 26.4% (95% CI: 17.4–35.4%). The number of cancers at each site was small; the sensitivity per site ranged from 0% to 53%. Combining these results and the assumption that the prevalence of breast cancer in an average-risk group of women 30–39 years of age, the authors estimated that for every 136 women with a positive T-Scan result, one would have cancer. If all T-Scan-positive women in this age group underwent mammography, it is estimated that about one in 194 women would have cancer (this estimate is lower because of the less than perfect sensitivity of mammography). The authors state that this detection rate is higher than would be found among a randomly selected group of 30- to 39-year old women or among women younger than 40 years of age with an affected first-degree relative (about one cancer detected in every 333 women). The relative probability of cancer in a T-Scan-positive woman is estimated to be 4.95 (95% CI: 3.16–7.14). These calculations apparently do not include the patients in whom T-Scans were attempted but not completed: 14 women in the specificity group and four women in the sensitivity group. Because of technical difficulties, 66 results in the second group were considered unreliable, but the authors argue that these problems might have been corrected if the examiners had not been blinded to the results and, therefore, were unaware of the problems; examiners in the specificity group were not blinded. The sensitivity of this test remains low, even in a group of women with a deliberately higher prevalence of cancer than would be expected in a screening population.

Further research has also been performed on the characteristics of electromagnetic breast imaging in distinguishing between normal breast tissue and abnormal tissue, and between cancerous and benign abnormal tissue. (16) EIS was one of the three electromagnetic imaging modalities used in women with mammography results rated as BI-RADS category 1 (negative; 53 women) or category 4 (suspicious for malignancy) or 5 (highly suspicious for malignancy; 97 women in “abnormal” group). The focus was on a prospective, quantitative assessment of the contrast in electromagnetic properties between normal and abnormal tissue. EIS results were available for 62 “abnormal” cases and 36 normal controls; EIS data were not available for 19 cases due to technical difficulties and 33 cases due to analytical difficulties (data calibration). EIS was found to help in discrimination between normal and abnormal tissue but “may not aid” in distinguishing between cancer and other abnormal pathological findings. Using results from all three modalities examined (EIS, microwave imaging spectroscopy, and near-infrared spectral tomography) did not substantially improve the ability to identify breast cancer.

In 2013, further research was completed by Vrugdenburg and colleagues. (17) The objective of this study aimed to systematically identify and evaluate all the available evidence of safety, effectiveness and diagnostic accuracy for 3 emerging classes of technology promoted for breast cancer screening and diagnosis: Digital infrared thermal imaging (DITI), electrical impedance scanning (EIS) and elastography.A systematic search of seven biomedical databases (EMBASE, PubMed, Web of Science, CRD, CINAHL, Cochrane Library, and Current Contents Connect) was conducted through March 2011, along with a manual search of reference lists from relevant studies.The principal outcome measures were safety, effectiveness, and diagnostic accuracy.Data were extracted using a standardized form, and validated for accuracy by the secondary authors. Study quality was appraised using the quality assessment of diagnostic accuracy studies tool, while heterogeneity was assessed using forest plots, Cooks' distance and standardized residual scatter plots, and I (2) statistics. From 6,808 search results, 267 full-text articles were assessed, of which 60 satisfied the inclusion criteria. No effectiveness studies were identified. Only one EIS screening accuracy study was identified, while all other studies involved symptomatic populations. Significant heterogeneity was present among all device classes, limiting the potential for meta-analyses. Sensitivity and specificity varied greatly for DITI (Sens 0.25-0.97, Spec 0.12-0.85), EIS (Sens 0.26-0.98, Spec 0.08-0.81) and ultrasound elastography (Sens 0.35-1.00, Spec 0.21-0.99). It is concluded that there is currently insufficient evidence to recommend the use of these technologies for breast cancer screening. Moreover, the high level of heterogeneity among studies of symptomatic women limits inferences that may be drawn regarding their use as diagnostic tools. Future research employing standardized imaging, research and reporting methods is required.

In 2007, Wang et al. (18) researched the electric impedance properties of breast tissue and demonstrated the different characteristic of EIS images. The impedance character of 40 malignant tumors, 34 benign tumors and some normal breast tissue from 69 patients undergoing breast surgery was examined by EIS in vivo measurement and mammography screening, with a series of frequencies set between 100 Hz - 100 kHz in the ex vivo spectroscopy measurement. Of the 39 patients with 40 malignant tumors, 24 showed bright spots, 11 showed dark areas in EIS and 5 showed no specific image. Of the 30 patients with 34 benign tumors there were almost no specific abnormality shown in the EIS results. Primary ex vivo spectroscopy experiments showed that the resistivity of various breast tissue take the following pattern: adipose tissue, cancerous tissue, mammary gland and benign tumor tissue. The authors noted there are significant differences in the electrical impedance properties between cancerous tissue and healthy tissue. The impedivity of benign tumor is lower, and is at the same level with that of the mammary glandular tissue. The distinct growth pattern of breast lesions determined the different electrical impedance characteristics in the EIS results.

In 2016, Daglar et al. (19) compared the usefulness of breast electrical conductivity measures against conventional breast screening modalities for identifying the symptomatic lesions of the breast tissue. A group of 181 patients were examined with ultrasonography, mammography, EIS modalities and were followed-up to 24 months to clarify in terms of the lesion tumor progression relationship. Tumor biopsy was determined as an endpoint of the study. Per ultrasonography, 13 (7.2 %) lesions were suspicious, whereas EIS reported 22 (12.2 %). Two of the 9 patients were presented as BI-RADS 4 and histopathologic result was proven as malignant disease during the 6-month short-interval follow-up. EIS exhibited compatible sensitivity (81.2 %), accuracy (84.6 %) and PPV (81.8 %) rates with ultrasonography in BI-RADS 4 subgroup, combination of these modalities raised sensitivity rates to 92.31 %, accuracy and PPV to 100 %. EIS results in BI-RADS 3 subgroup were pointed out 77.8 % specificity and 87.5 % NPV rates. The author concluded that breast electrical impedance measures should be useful to reduce the number of the unnecessary follow-up and biopsy rates in the clinical setting.

Professional Guidelines and Position Statements

Society of Breast Imaging (SBI)

The 2010 SBI Position Statement (20) affirms:

“There are no large, peer-reviewed published studies that support the routine use of other imaging techniques such as thermography, sestimibi, PET, transillumination, electrical impedance scanning, or optical imaging for breast cancer screening. The American College of Radiology (ACR) and SBI do not endorse thermography or any of these other modalities for screening for breast cancer.”

National Comprehensive Cancer Network (NCCN)

The 2016 NCCN Clinical Practice Guideline for Breast Cancer Screening and Diagnosis (21) does not mention EIS as a diagnostic tool in the diagnosis or management of breast tumors.

The 2017 NCCN Clinical Practice Guideline for Breast Cancer (22) does not mention EIS as a diagnostic tool in the diagnosis or management of breast tumors.

Summary of Evidence

There is insufficient evidence in the scientific literature to support the diagnostic utility of Electrical Impedance Scanning (EIS) of the breast as an adjunct to mammography. The separation of malignant verses benign tumors based on EIS measurements need further investigation. Additional well designed long term studies are needed to determine if EIS is as effective as mammography and the impact on health outcomes.


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Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

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1. U.S. Food and Drug Administration. Summary of safety and effectiveness data: T-Scan 2000 (P050003). April 1999. Available at <>. (accessed May 23, 2017).

2. FDA - Mirabel Medical Systems, Inc. T-Scan™ 2000ED (P050003) Draft Discussion Questions. Federal Drug Administration - Obstetrics and Gynecology Devices Panel (2006 August 29). Available at <>. (accessed May 23, 2017).

3. Kao T.J., Boverman G., Isaacson D., et al. Regional admittivity spectra with tomosynthesis images for breast cancer detection. Conf Proc IEEE Eng Med Biol Soc. 2007; 2007:4142-5. PMID 18002914

4. Trokhanova O.V., Okhapkin M.B., Korjenevsky A.V., Dual-frequency electrical impedance mammography for the diagnosis of non-malignant breast disease. Physiol Meas. 2008; 29(6):S331-44. PMID 18544828

5. Weerakkody, Y. Breast imaging-reporting and data system (BIRADS) (November 2015). Available at <> (accessed May 23,2017).

6. Perlet C., Kessler M., Lenington S., et al. Electrical impedance measurement of the breast: effect of hormonal changes associated with the menstrual cycle. Eur Radiol. 2000; 10(10):1550-4. PMID 11044923

7. Martin G., Martin R., Brieva M.J., et al. Electrical impedance scanning in breast cancer imaging: correlation with mammographic and histologic diagnosis. Eur Radiol. 2002; 12(6):1471-8. PMID 12042956

8. Malich A., Bohm T., Facius M., et al. Additional value of electrical impedance scanning: experience of 240 histologically proven breast lesions. Eur J Cancer. 2001; 37(18):2324-30. PMID 11720824

9. Wersebe A., Siegmann K., Krainick U., et al. Diagnostic potential of targeted electrical impedance scanning in classifying suspicious breast lesions. Invest Radiol. 2002; 37(2):65-72. PMID 11799329

10. Malich A., Boehm T., Facius M., et al. Differentiation of mammographically suspicious lesions: evaluation of breast ultrasound, MRI mammography and electrical impedance scanning as adjunctive technologies in breast cancer detection. Clin Radiol. 2001; 56(4):278-83. PMID 11286578

11. Malich A., Fritsch T., Anderson R., et al. Electrical impedance scanning for classifying suspicious breast lesions: first results. Eur Radiol 2000; 10(10):1555-61. PMID 11044924

12. Fuchsjaeger M.H., Flory D., Reiner C.S., et al. The negative predictive value of electrical impedance scanning in BI-RADS category IV breast lesions. Invest Radiol. 2005; 40(7):478-85. PMID 15973141

13. Stojadinovic A., Nissan A., Gallimidi Z., et al. Electrical impedance scanning for the early detection of breast cancer in young women: preliminary results of a multicenter prospective clinical trial. J Clin Oncol. 2005; 23(12):2703-15. PMID 15837985

14. Stojadinovic A., Moskovitz O., Gallimidi Z. et al. Prospective study of electrical impedance scanning for identifying young women at risk of breast cancer. Breast Cancer Res Treat. 2006; 97(2):179-89. PMID 16491309

15. Stojadinovic A., Nissan A., Shriver C.D., et al. Electrical impedance scanning as a new breast cancer risk stratification tool for young women. J Surg Oncol. 2008; 97(2):112-20. PMID 18050282

16. Poplack S.P., Tosteson T.D., Wells W.A., et al. Electromagnetic breast imaging: results of a pilot study in women with abnormal mammograms. Radiology. 2007; 243(2):350-9. PMID 17400760

17. Vreugdenburg T.D. A systematic review of elastography, electrical impedance scanning and digital infrared thermography for breast cancer screening and diagnosis, Breast Cancer Res Treat. (2013 February) 137(3):665-76. PMID 23288346

18. Wang, K., Wang, T., et al. Electrical impedance scanning in breast tumor imaging: correlation with the growth pattern of lesion. Chinese Med J. (Eng.) (2009 July 5) 122(13):1501-6. PMID 19719937

19. Daglar G. Senol K., Yakut Z., et al. Effectiveness of breast electrical impedance imaging for clinically suspicious breast lesions. Bratisl Lek Listy. 2016;117(9):505-510. PMID 27677193

20. Lee, C. Breast cancer screening with imaging: recommendations from the Society of Breast Imaging and the ACR on the use of mammography, breast MRI, breast ultrasound, and other technologies for the detection of clinically occult breast cancer. J Amer Coll Radiol: JACR 7.1 (2010):18. PMID 20129267

21. National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology. Breast Cancer Screening and Diagnosis. V2.2016. Available at <> (accessed May 24, 2017).

22. National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology. Breast Cancer. V2.2017. Available at <> (accessed May 30, 2017).

23. Electrical Impedance scanning of The Breast, Chicago, Illinois: Blue Cross Blue Shield Association, Medical Policy Reference Manual (Archived December 2009) Medicine 2.01.63.

Policy History:

Date Reason
6/15/2018 Reviewed. No changes.
7/15/2017 Document updated with literature review. Coverage unchanged.
7/15/2016 Reviewed. No changes.
8/1/2015 Document updated with literature review. Coverage unchanged.
9/1/2014 Reviewed. No changes.
10/15/2013 Document updated with literature review. Coverage unchanged.
9/1/2010 Document updated with literature review. Coverage unchanged.
4/15/2008 Document updated with literature review.
2/1/2005 New medical document.

Archived Document(s):

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