Magnetic Resonance Imaging (MRI)

The February 24, 2011 Decision Memo regarding the second reconsideration for Magnetic Resonance Imaging (MRI) discussed implanted permanent pacemakers and implantable cardioverter defibrillators (ICDs), however the third reconsideration addresses only pacemakers. We would suggest that CMS also include ICDs in this most recent reconsideration and adopt the same standards that are being proposed for pacemakers. That is, that CMS allow coverage for MRIs for patients with ICDs when such ICDs are used according to the FDA-approved labeling for use in an MRI environment. While there may not be an approved MRI safe ICD device today, this would allow for coverage of these services when such a device becomes available without a delay due to the NCD reconsideration process.

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Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Office of Clinical Standards and Quality
Coverage and Analysis Group
7500 Security Blvd
Mail Stop C1-09-06
Baltimore, MD

SUBMITTED ELECTRONICALLY

RE: Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R3)

Dear Dr. Jacques:

The North American Society for Cardiovascular Imaging (NASCI) and the American College of Radiology (ACR) applaud CMS’s efforts with their April 25, 2011 Proposed National Coverage Determination on Magnetic Resonance Imaging. Our societies agree with and support CMS’s proposed decision that “the evidence is adequate to conclude that magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers (PMs) when the PMs are used according to the FDA-approved labeling for use in an MRI environment. Therefore we propose that this use of MRI is reasonable and necessary under §1862(a)(1)(A) of the Social Security Act (the Act.)” NASCI and ACR are pleased with CMS’s proposed decision to allow national coverage for MRI scans that are FDA approved pacemakers. FDA's approval of specific implanted pacemakers as safe and effective for use with MRIs is sufficient as the standard of safety for these devices. Based on this CMS decision, patients with FDA-approved devices will now have the same access to medically necessary MRIs as patients without implanted cardiac devices. NASCI and ACR appreciate CMS’s Proposed Decision Memorandum on MRI and support a positive final National Coverage Determination.

If you have any questions, please contact Anita McGlothlin at amcglothlin@acr.org or 703-648-8923 ext. 4923.

Respectfully Submitted,

Geoffrey D. Rubin, MD
President-elect, North American Society for Cardiovascular Imaging
Harvey L. Neiman, MD, FACR
Chief Executive Officer, American College of Radiology

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May 25, 2011

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop: C1-09-06
7500 Security Blvd.
Baltimore, MD 21244

RE: Proposed Decision Memorandum for Magnetic Resonance Imaging (MRI) (CAG-00399R3)

Dear Dr. Jacques:

The Medical Imaging and Technology Alliance (MITA) appreciates this opportunity to comment on the proposed decision memorandum for magnetic resonance imaging (MRI) (CAG-00399R3). As the leading trade association representing medical imaging and radiotherapy technology manufacturers, we have an in-depth understanding of the significant benefits to the health of Medicare beneficiaries that medical imaging, radiotherapy and proton therapy provides. MITA is pleased to work with the Centers for Medicare & Medicaid Services (CMS) to ensure appropriate use and access to imaging services, including MRI.

Medical imaging encompasses X-ray imaging, computed tomography (CT) scans, radiation therapy, related image acquisitions, diagnostic ultrasound, nuclear medical imaging (including positron emission tomography (PET)), and magnetic resonance imaging (MRI). Medical imaging is used to diagnose patients with disease, often reducing the need for costly medical services and invasive surgical procedures.¹ In addition, medical imaging equipment often is used to select, guide and facilitate effective treatment, for example, by using image guidance for surgical or radiotherapeutic interventions.² MITA’s members also develop and manufacture innovative radiotherapy equipment used in cancer treatment.

In the proposed decision memorandum, CMS reviews the evidence regarding use of MRI with a pacemaker (PM) approved by the Food and Drug Administration (FDA) for use during certain MRI exams. Based on this evidence, CMS proposes that “the evidence is adequate to conclude that MRI improves health outcomes for Medicare beneficiaries with implanted PMs when the PMs are used according to the FDA-approved labeling for use in an MRI environment.”³ CMS proposes to revise the National Coverage Determination (NCD) Manual to remove the current contraindication for Medicare coverage of MRI in beneficiaries with implanted PMs, but any other contraindications listed in the manual would continue to apply if present in these beneficiaries.⁴

MITA strongly supports this proposal because it will help expand access to appropriate imaging services for beneficiaries with certain implanted PMs. As CMS recognizes, “MRI clearly leads treating physicians to change their diagnostic or treatment strategies in such a way that better outcomes are achieved for many conditions.”⁵ Medicare coverage of MRI for beneficiaries with appropriate PMs will allow these patients and their physicians to use an important option for diagnosing and planning treatments for cancer, multiple sclerosis, and other conditions. We urge CMS to finalize this decision immediately.

We also commend CMS for considering the evidence presented for this coverage analysis “in the larger context of the vast body of evidence on MRI that [CMS] has considered previously.”⁶ This body of evidence, combined with the FDA’s approval of the Medtronic Revo MRI SureScanTM Pacing System and the published evidence reviewed in the proposed decision memorandum, provide ample proof that use of MRI for beneficiaries with implanted PMs that are approved for use in the MRI environment improves health outcomes and is reasonable and necessary. No further study is needed to support coverage of MRI for these beneficiaries.

We are pleased that CMS acted quickly to update its coverage policy after FDA approval of the Medtronic Revo MRI SureScanTM Pacing System, the first PM approved for use during certain MRI exams. We also support the proposed revision to the NCD Manual because it will allow beneficiaries with this system or any system subsequently approved by the FDA for use in the MRI environment to have necessary scans covered by Medicare, without requiring another reconsideration of the NCD.

We appreciate this opportunity to submit these comments. If you have any questions or would like to discuss these matters further, please contact me at 703-841-3279. Thank you for consideration of these comments.

Respectfully submitted,

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May 25, 2011

Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00399R3

Dear Sir/Madam:

On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and over 22.5 million AHA and ASA volunteers and supporters, we appreciate the opportunity to submit our comments in response to the Centers for Medicare and Medicaid Services (CMS) proposed decision memo for magnetic resonance imaging (MRI).

According to the proposed decision memo, CMS intends to expand Medicare coverage of MRI to beneficiaries with implanted permanent pacemakers when the pacemakers are used according to FDA-approved labeling for use in an MRI environment. AHA supports this proposal.

Safety of MRI in Patients with a Pacemaker
Implanted permanent pacemakers have historically been listed as a contraindication for Medicare coverage of MRI due to a number of safety concerns, including concern that the pacemaker would affect the interpretation of the MRI or that the MRI would affect the proper functioning of the implanted device. While AHA agrees that the presence of a pacemaker can be considered a contraindication for MRI, magnetic resonance scanning can be conducted safety in these patients if certain precautions are taken. In the 2007 AHA Scientific Statement: Safety of Magnetic Resonance Imaging in Patients with Cardiovascular Devices, AHA advised health care providers to take precautions such as monitoring the patient’s heart rhythm and vital signs throughout the procedure, having appropriate personnel plan and conduct the scan, and interrogating the pacemaker before and after the procedure.

AHA made these recommendations regarding proper use of MRI in patients with cardiovascular devices in recognition of the growing use of MRI as a diagnostic imaging modality, and the increasing number of patients being treated with an implanted cardiovascular device. It has been estimated that a patient with a pacemaker has a 50 to 75% likelihood of having a clinical indication for MRI over the lifetime of their device.¹

In our Scientific Statement, the Association also called for the development of pacemakers and other implanted devices that are specifically designed to be safe for patients undergoing an MRI procedure. Although ad hoc tests and practical experience have provided good evidence that MRI can be conducted safely in patients with pacemakers and other implanted cardiovascular devices, clinical trial data supporting the use of these devices, designed for and shown to be safe in the MRI environment, will provide health care providers and their patients with additional assurance when selecting the best imaging modality.

Medicare Coverage of MRI in Patients with a Pacemaker
AHA is aware that an implanted permanent pacemaker recently received FDA-approval for use in the MRI environment. That approval was supported by data from a randomized, controlled clinical trial that showed “no MRI-related complications, no disturbances of pacemaker function, and no ventricular arrhythmia induction” when used under well-defined conditions.² That evidence – and the subsequent FDA-approval of the device – served as the basis for CMS’s proposal to expand Medicare coverage of MRI to patients with implanted permanent pacemakers that are used according to FDA-approved labeling for use in a MRI environment.

AHA is pleased that sufficient clinical trial evidence was available for both the FDA and CMS to evaluate the safety of implanted permanent pacemakers when used with precautions similar to those described in our Scientific Statement. And we support CMS’s proposal to follow the FDA-approved labeling and remove the contraindication for pacemakers when used according to FDA labeling for use in a MRI environment. Implanted permanent pacemakers and other implanted cardiovascular devices that receive FDA-approval for use in the MRI environment should be eligible for Medicare coverage. We anticipate that other manufacturers will also have FDA-approved devices in the future that will meet these requirements.

We, therefore, encourage CMS to revise its MRI coverage policy as proposed and release the final coverage decision as soon as possible.

Thank you for consideration of our comments. If you have any questions or need any additional information, please do not hesitate to contact Susan Bishop, MA, Regulatory Affairs Manager, at 202-785-7908 or susan.k.bishop@heart.org.

Sincerely,

________________________

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May 25, 2011

Louis B. Jacques, MD
Director
Coverage and Analysis Group
Centers for Medicare and Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

Re: Magnetic Resonance Imaging (MRI) (3rd Recon) (00399R3)

Dear Dr. Jacques:

The Heart Rhythm Society and the American College of Cardiology are pleased to submit comments on the Proposed Decision Memorandum on Magnetic Resonance Imaging, 3rd reconsideration. We submitted previous comments in response to the Decision Memorandum on Request for the 2nd Reconsideration of Magnetic Resonance Imaging. In those comments, we noted that the number of patients with cardiac electrical devices has expanded substantially in recent years. At the same time, and because of its unique capabilities, MRI emerged as a critical tool for evaluating patients with a variety of diseases or conditions. As a result of these developments, there are an increasing number of patients who have implantable devices and also present with the standard indications for MRI. In our comments submitted in December 2010, we also stressed that FDA-approval should be a minimum requirement for safely imaging pacemaker patients outside of a clinical trial setting. In response to the third reconsideration, we support the proposed determination that CMS remove the contraindication in the MRI policy for patients with pacemaker devices that have been approved by the FDA for use in the MRI environment. This coverage supports the expansion of health care options and access to health care services for patients with implantable devices. We support safeguards, education, guidelines and protocols to authenticate or validate the FDA-approved care pathways used during an MRI scan when a patient with an implanted FDA-approved MRI cardiac electrical device receives a scan. We recommend that CMS delineate in the coverage determination the steps that facilities must take to avoid an adverse event or circumstances of unintended non-coverage due to misclassification of a device which is not FDA-approved for use in a MRI environment. Lastly, we are committed to ongoing clinical research to investigate the safety of MRI in a circumstance in which it is deemed to be an essential examination in the context of a life threatening disease in a patient with a device not approved for the MRI environment. Thank you for your consideration. We look forward to ongoing dialogue with CMS.

If you have questions, please contact Kimberley Moore via e-mail at kmoore@hrsonline.org.

Sincerely,

* Dr. Wilkoff was a coordinating investigator for the EnRhythm MRI randomized clinical trial, lead author of the publication of the trial results, participated in the presentation before the FDA panel of the PMA application and was an unpaid consultant for Medtronic during the development and testing of the EnRhythm MRI pacemaker.

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May 24, 2011

Louis B. Jacques, MD
Director
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Magnetic Resonance Imaging (MRI) (CAG-00399R3)

Dear Dr, Jacques:

The Society for Cardiovascular Magnetic Resonance (SCMR) is pleased to submit comments on the National Coverage Determination (NCO) for Magnetic Resonance Imaging (MRI) with plans for Continuing Evidence Development (CEO) and appreciates this opportunity to provide comment. Our society agrees that patients with an implanted device may undergo MRl scanning if 1) the MRI is clearly clinically indicated, 2) the MRl staff-including physicians, nurses, and technologists -are adequately versed in appropriate device management and patient care in the MRI setting, and 3) there is strict adherence to documented operating instructions, including appropriate precautionary measures, patient screening, device and patient monitoring and followup.

The SCMR is the recognized representative and advocate for physicians, scientists, and technologists who work in the field of cardiovascular magnetic resonance (CMR). We are viewed, both nationally and internationally, as the principal independent organization committed to the further development of CMR through education, quality control, research, and training. As specialists in both cardiovascular diseases and MRl, we believe that our society is particularly well-suited to address the issues pertaining to MRl of patients with cardiac devices. We strongly believe that patients must have access to appropriate diagnostic technology and we offer the following comments on this National Coverage Analysis.

The number of patients with implantable cardioverter defibrillators (lCDs) or pacemakers has expanded substantially in recent years. Because of its unique capabilities, MRl has become a critical tool for evaluating patients with a variety of diseases and conditions. As a result of these developments, the number of patients who have implantable devices and also present with the standard indications for MRl is increasing. However, patients with pacemakers or ICDs are currently restricted from having MRI scans because of potentially life-threatening risks.¹ Pacemakers are one of only two devices specifically contraindicated for MRI scanning in the original policy, which was developed in 1994. Since that time, industry has worked to develop MRI conditional pacemakers and ICDs that address the safety concerns expressed by the FDA in the 2006 editorial in Circulation by Faris and Shein² . The recent development of an FDA approved, MRI safe pacemaker (Medtronic Revo MRJTM SureScan™ System)-in distinction to 'MRI conditional'-represents an important milestone in device manufacturing, and it indicates clear recognition by industry of the paramount importance of patient safety and MRI access. The SCMR supports the proposition that CMS remove the contraindication in the MRI policy for patients with pacemaker devices that have been FDA approved as MRI safe. Furthermore, we welcome the decision by CMS to provide coverage of MRI examinations in patients with such devices.

However, there are numerous recent studies that show that MRI, when done with the appropriate safeguards, can be performed safely on patients with virtually any make or model of pacemakers or ICDs. Accordingly, the SCMR strongly urges CMS to reverse its decision to deny coverage ofMRI examinations performed in patients with devices that are not FDA approved as MRI safe. The SCMR believes that a decision to deny coverage for MRI on beneficiaries with these devices could seriously undermine the appropriate clinical management of a small but growing population of patients.

Finally, the SCMR recommends that CMS delineate in the coverage determination that MRI protocols should comply with the recommendations for the performance ofMRI in patients with pacemakers or ICDs made in the American Heart Association Scientific Statement on the safety of MRI in patients with cardiovascular devices³

Thank you for your consideration, we look forward to continued dialogue with CMS. If you have questions, please contact Denise Garris at (202) 527-1069 or denise@korrisgroup.com.

Sincerely,

/s/
Scott D. Flamm, MD
President, Society for Cardiovascular Magnetic Resonance

¹Hayes DL, Lloyd MA, Friedman PA. Cardiac pacing and defibrillation: A clinical approach. 2000 Futura Publishing Company, Inc.

²Faris 0, Shein M. Food and Drug Administration Perspective Magnetic Resonance Imaging of Pacemaker and Implantable Cardioverter-Defibrillator Patients. Circulation 2006; 114:1232-1233.

³ Levine GN, Gomes AS, Arai AE, Bluemke DA, Flamm SO, Kana! E, Manning WJ, Martin ET, Smith 1M, Wilke N, Shellock FS. Safety of magnetic resonance imaging in patients with cardiovascular devices. An American Heart Association Scientific Statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and Council on Cardiovascular Radiology and Intervention. Circulation 2007;116:2878-2891.

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May 17, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Office of Clinical Standards and Quality
Coverage and Analysis Group
7500 Security Blvd.
Mail Stop C1-09-06
Baltimore, MD 21244

National Coverage Analysis (NCA) for Magnetic Resonance Imaging (MRI) (CAG-00399R3) – Final Open Comment Period

Dear Dr. Jacques:

Thank you for your expeditious completion of the Proposed Decision Memorandum on Magnetic Resonance Imaging posted on April 25, 2011. We appreciate the very quick turnaround and fully support the CMS findings in which it states:

Medtronic is entirely supportive of the proposed decision to allow MRI scan coverage for FDA-approved pacemakers and we encourage CMS to finalize this policy as proposed. We also provide some technical comments on the decision analysis in the attached appendix. Thank you for the opportunity to comment.

Sincerely,

Bob Thompson, MS., MA.
Senior Director, Reimbursement, Economics and Health Policy
Cardiac Rhythm Disease Management
Medtronic, Inc.
8200 Coral Sea Street NW, MVS33
Mounds View, MN 55112
763-526-2936
bob.thompson@medtronic.com

In the proposed Decision Memorandum CMS states:

With regard to this discussion, we wish to clarify that it was not our intent in the initial proposed language to repeal the February 24, 2011 exception for coverage in clinical studies. In our view, the two Decision Memoranda represent parallel circumstances, the February 24 decision addressing reimbursement under clinical studies and the April 25 Proposed Decision Memorandum addressing FDA-approved product. It was not our intent to address the February 24 decision in this reconsideration. We regret any confusion our proposed language may have caused.

In the proposed Decision Memorandum CMS states:

1. An intent to treat analysis was not followed.”

Medtronic wishes to clarify that an intention-to-treat analysis was performed and is reported on page 69 of the publication.

In the proposed Decision Memorandum CMS states:

Medtronic wishes to clarify that the statistical analysis for the publication was performed by Medtronic, and was independently confirmed by an outside academic research organization as reported on page 68 of the manuscript.

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Louis B Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services (CMS)

Re: Proposed Decision Memo for Magnetic Resonance Imaging (CAG-00399R2)

Dear Dr Jacques and Colleagues:

We wish to respond to the Decision Memo for Magnetic Resonance Imaging (CAG-00399R2) coverage for patients with implanted cardiac pacemakers (PMs) or cardioverter defibrillators (ICDs) and to your additional request for input regarding coverage for pacemakers now emerging as FDA-approved as MRI safe/compatible. The referenced memo proposes to exclude from coverage MRI studies in patients with PMs or ICDs except those enrolled in clinical trials or approved registries. Although we applaud the concern for careful selection of patients and oversight of MRI studies in patients with PMs or ICDs, we believe the proposed restrictions/contradictions in coverage may be excessive and raise medical and ethical concerns. However, if the proposed coverage decision stands, we strongly encourage a commitment to allow coverage for centers that follow strict guidelines for application and qualify for formal registry status. Secondly, we strongly support coverage for patients who receive an FDA-approved, MRI compatible device under FDA-specified conditions and for recognized clinical indications without further restriction. We base these comments/suggestions on general and personal experience as reviewed below:

Based on emerging and reassuring safety information from several centers by 2004 and a strong and evident clinical need, our center began performing MRIs over six years ago with individual written informed consent and under a clearly defined protocol in selected patients with PMs or ICDs. For example, patients were excluded if they were pacemaker dependent, if they had older devices (i.e., before 2000), if they had a device other than from a previously tested manufacturer (i.e., Medtronic, St. Jude, Guidant/Boston Scientific), and if the necessary medical information could be obtained with another modality (e.g., computed tomography). In addition, pre-approval by both radiology and cardiology (electrophysiology) is required, continuous ECG and blood pressure monitoring is used, emergency resuscitation equipment is readily available, and constant in-lab pacemaker expertise (i.e., specialized physician assistant and/or physician) and in-house electrophysiology back-up is provided.

Since initiating this program, our center has performed MRIs in well over one-hundred patients. There has been not a single instance of device injury requiring replacement or significant patient injury. In contrast, information highly relevant to patient diagnosis, prognosis, and therapy has been obtained routinely (e.g., brain tumors in undiagnosed patients with mental status changes, CNS abscesses, spinal cord pathology). Hence, the benefit to risk ratio in our own experience is clearly positive. Our experience also is consistent with multiple reports (published and unpublished) from many other highly specialized and reliable centers, which have used a similar carefully selected and monitored approach to testing and found it to be safe and effective.

Thus, although we agree with the proposal that these MRIs be performed in highly regulated settings, we are concerned about the call for randomized clinical trials. We believe that a randomized clinical trial (i.e., with the possibility of no MRI) in the settings in which we have used MRI for device patients would be unethical. Indeed, we believe the benefit /risk ratio, based on personal careful observations under our protocol, has been so high as to preclude randomized trials of MRI imaging against none. For example, a recent patient with an ICD was imaged for an abscess eroding a vertebral body and impinging on his spinal cord, which was diagnosed safely by MRI and was critical to patient management. This case now requires follow-up imaging to ensure a satisfactory course with treatment, but the new non-payment rule has put his treatment course and outcome in jeopardy. Randomized trials require therapeutic equipoise, this is clearly is not the case.

On the other hand, we would be supportive of using MRI in a more formal registry setting. We attach for your consideration our current guidelines for MRI application in patients with rhythm management devices and suggest that under these guidelines an Intermountain Healthcare Registry can be appropriately configured, and we would be willing to supply composite information quality assurance information, and, if properly consented and necessary, individual case information.

Given the excellent safety record with newer but standard devices from at least the 3 major device manufacturers mentioned, we are inclined to be highly supportive of coverage for next generation devices that they have developed (or are in process of developing) and have carefully tested (under FDA-guidance and scrutiny) and have been formally approved as MRI-safe and compatible. We see these devices as initially being chosen selectively for those patients needing pacing and with concomitant medical conditions that forecast a clear ongoing or future need for MRI evaluation. A note of concern: if patients with modern but non-MRI approved devices are not provided with acceptable coverage options in appropriately configured registries, then physicians may be forced to implant an unduly high percentage of these new-generation, higher-cost, often lower-functionality MRI-approved devices, because predicting everyone who will need MRI scans in their future clearly is an impossible task.

In conclusion, we ask you to consider the following: 1) allow coverage for medically necessary MRI imaging in patients with newer standard devices (i.e., after 2000 Medtronic, St Jude, Boston Scientific) in centers with clearly established, appropriate guidelines and experience for their application, and which can provide quality assurance information (i.e., that can function as registries); 2) favorably consider our own request to function as such a registry under the attached guidelines’ proposal, and 3) provide coverage for clinically indicated MRI studies in patients with devices that are FDA-approved as MRI safe/compatible without further restriction. We thank you in advance for your interest in and attention to these concerns and requests.

Sincerely yours,

Jeffery Anderson, MD
Associate Chief of Cardiology

Allison Tonkin, MD
MRI Clinical Director, Mountain Medical Physician Associates

Don Lappe, MD
Medical Director, Intermountain Cardiovascular Clinical Program Chief of Cardiology
Chairman, Cardiovascular Department Intermountain Medical Center

Tom Bonk MD
Mountain Medical Physician Associates

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Thursday, May 12, 2011; 9:45 PM

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Office of Clinical Standards and Quality
Coverage and Analysis Group
7500 Security Blvd.
Mail Stop C1-09-06
Baltimore, MD 21244

Dear Dr. Jacques:

I would like to take this opportunity to thank you for your remarkably rapid reconsideration and decision regarding the Proposed Decision Memorandum (PDM) for MRI. I know that many, including I, had written to urge your reconsideration and acceptance of the FDA's approval of the Revo Surescan MR Conditional Cardiac Pacing System for reimbursement for clinically indicated MRI examinations. In truth, I had expected that this process would be drawn out and prolonged, and that many might suffer in the interim with either needless delays, cancellations, or referrals to more risky or even invasive procedures while waiting for this to be reconsidered. I am MOST impressed with the rapidity with which you/CMS have re-evaluated your position on this issue, and cannot thank you enough for the speed with which you have rectified a previously held most difficult position. I can only reaffirm for you that you have made the right decision, and that quite literally hundreds, and shortly, thousands or tens of thousands - and their loved ones - will be so very glad that CMS has accepted these devices for what they are: A true breakthrough in MR safety for these patients, and nothing less than merely the start of an entire new era in MRI diagnostic access for the 2 million cardiac device patients in the US today.

I salute and thank you and your staff for your most timely and appropriate re-evaluation, reconsideration, and decision. If I can be of any assistance, now or in the future, please feel strongly encouraged to contact me directly via any of the means listed below.

Thank you one and all once again! Best wishes and be well - always -

Emanuel Kanal, MD, FACR, FISMRM< AANG
Chair, Magnetic Resonance Safety Sub-Committee
American College of Radiology
Director, Magnetic Resonance Services
Department of Radiology
University of Pittsburgh Medical Center
Professor of Radiology and Neuroradiology
Office: 412-647-3540
Home: 412-4321-9927
Cell: 412-418-1828
Fax: 412-422-8714
ekanal@pitt.edu

5534 Forbes Avenue
Pittsburgh, PA 15217-1126

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