RevoMRISureScanPacemaker-MedtronicCRDMDevice:revoMRIsurescan起搏器-美敦力CRDM装置.ppt
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1、FDA approved for MRI use The first pacing system to break the image barrier,The Revo MRI SureScan pacing system is MR Conditional designed to allow patients to undergo MRI under the specified conditions for use. A complete system, consisting of a Medtronic Revo MRI SureScan IPG implanted with two Ca
2、pSureFix MRI SureScan leads is required for use in the MRI environment.,The First and Only Pacing System FDA Approved for MRI Use,Specifically engineered for MRI safety, with reliable lead technology and a proven pacemaker platform this is state-of-the-art pacing. Now your patients get proven cardia
3、c care with MRI access.,Meeting the Need for MRI,Pacemaker Implants in an Aging Population The number of pacemakers currently implanted in the United States is approximately 1.5 million1,2,Elderly patients are the primary users of MRI: individuals over age 65 are twice as likely to need an MRI compa
4、red to younger recipients.3,Average Age of Pacemaker Patient,13% Ages 25-64,86% Age 65+,1 Kalin R, Stanton MS. PACE. 2005;28:326-328. 2 Zhan C, et al. Gen Intern Med. 2008;23:13-19. 3 Global Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment a global strategic business report. San Jo
5、se, CA. 2002.,Part of Comprehensive Patient Care,Now, for the first time, you can implant a state-of-the-art pacing system to provide proven cardiac care AND MRI access when your patients need it Number of Comorbidities in Pacemaker Patients,Given that 85% of all pacemaker patients have one or more
6、comorbidities, facilitating comprehensive multispecialty care is important in todays environment,Medical and Surgical Specialties Rely on MRI for Diagnosis Your choice can affect their decisions and diagnostic capabilities,15% 0 comorbidities,30% 1 comorbidity,28% 2 comorbidities,27% 3 or more comor
7、bidities,Opthalmology,Otolaryngology,Neurosurgery,Neurology,Cardiothoracic Surgery,Surgical Oncology,Nephrology,Gynecologic Oncology,Urology,Rheumatology,Oncology,Radiation Oncology,Interventional Radiology,Gastrointestinal Surgery,Orthopedic Surgery,Vascular Surgery,85%1 1 or more comorbidities,1 K
8、alin R, Stanton MS. PACE. 2005;28:326-328.,Prevalence of Common Comorbidities in the Pacemaker Patient Population,The Prevalence of Common Comorbidities Increases Rapidly Over Age 65.1-3,MRI Is the Gold Standard Diagnostic Tool for Neurologists, Oncologists, and Orthopedic Surgeons, Whose Patients A
9、re Often Over 65 Years of Age.4 MRI is unmatched in its ability to accurately visualize soft tissue It is estimated that 50 to 75% of pacemaker patients will have a medical need for an MRI over the lifetime of their device5 The Most Common Reasons for MRI Referral Are Musculoskeletal and Neurologica
10、l Symptoms.6 Medicare records show that in patients 65 years of age with an implanted pacemaker: 34% have spine and intervertebral disc disease7 36% have chronic pain of wrist, foot, ankle, or elbow7 14% suffer from injury or trauma to the spine, knee, or shoulder7,1 National Cancer Institute April
11、2009. US estimated complete prevalence (including counts) by age on 1/1/2006. Based on November 2008 SEER data submission; DCCPS, Surveillance Research Program, Statistical Research and Applications Branch. 2 Lawrence RC, et al. Arthritis Rheum. 1998;41:778-799. 3 American Heart Association. Heart D
12、isease and Stroke Statistics 2010 Update: Learn and Live. Prevalence of stroke by age and sex (NHANES: 2003-2006). 4 Magnetic Resonance Imaging (MRI) Equipment A global Strategic Business Report, Global Industry Analysts, Inc., San Jose, CA 2002. 5 Kalin R, Stanton MS. PACE. 2005;28:326-328. 6 Medic
13、al Imaging Survey, 2009. 7 Medicare Fee-for-Service Review, 2007.,Hazards and Risks of MRI with Current Pacing Systems,Since 2008, the safety and risk concerns of MRIs in cardiac device patients have been documented in 17 studies.1-17 MRI can put pacemaker patients at risk for any of the following16
14、:,1 Naehle CP, et al. Pacing Clin Electrophysiol. 2009;32:1526-1535. 2 Goldsher D, et al. Pacing Clin Electrophysiol. 2009;32:1355-1356. 3 Gimbel JR. Europace. 2009;11:1241-1242. 4 Naehle CP, et al. J Am Coll Cardiol. 2009;54:549-555. 5 Roguin A. J Am Coll Cardiol. 2009;54:556-557. 6 Mollerus M, et
15、al. Pacing Clin Electrophysiol. 2008;31:1241-1245. 7 Pulver AF, et al. Pacing Clin Electrophysiol. 2009;32:450-456. 8 Nordbeck P, et al. Magn Reson Med. 2009;61:570-578. 9 Sutton R, et al. Trials. 2008;9:68. 10 Naehle CP, et al. Radiology. 2008;249:991-1001.,11 Calcagnini G, et al. J Magn Reson Imag
16、ing. 2008;28:879-886. 12 Dyrda K, Khairy P. Expert Rev Cardiovasc Ther. 2008;6:823-832. 13 Gimbel JR. Pacing Clin Electrophysiol. 2008;31:795-801. 14 Nordbeck P, Bauer WR. Dtsch Med Wochenschr. 2008;133:624-628.Article in German. 15 Tandri H, et al. Heart Rhythm. 2008;5:462-468. 16 Roguin A, et al.
17、Circulation. 2004;110:475-482. 17 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval.,MR Conditional Risk Information A complete SureScan pacing system including a Revo MRI SureScan IPG and two CapSureFix MRI SureScan leads is required for use i
18、n the MRI environment Any other pacing system combination may result in a hazard to the patient during an MRI scan When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing Refer to the Revo MRI Pacing System Cond
19、itions for Use located in the device manuals prior to scanning a patient. Consult Medtronics website at or call Medtronic at 1 (800) 328-2518.,Specifically Engineered for MRI Safety,Device Design Solutions Input circuits optimized Circuit design immune to interference SureScan Pacing Mode Asynchron
20、ous pacing High pacing outputs,The Revo MRI SureScan pacing system has completed clinical evaluation, regulatory review, and FDA approval; it is safe for use when used according to the MRI conditions for use as defined in the SureScan manual The implanted system must consist solely of a Medtronic Re
21、vo MRI SureScan Model RVDR01 device and two CapSureFix MRI SureScan Model 5086 MRI leads Revo MRI SureScan Pacemaker A Pacemaker Engineered with Multiple Safety Features Device verification appears on pacemaker programmer screen Automatic testing ensures only appropriate battery and impedance data a
22、re collected during MRI Dedicated programming mode provides additional security/backup for power on reset (POR) Hall sensor is immune to strong magnetic fields Easily Identifiable, Radiopaque Icon Confirms SureScan Device Implant,Specifically Engineered for MRI Safety,Lead Heating Design Solution Le
23、ad inner conductor coil design mitigates lead heating 4 filar to 2 filar increases inductance and reduces heating,Materials identical to 5076* Model 5086MRI lead flex testing Connector/body Lead body Model 5086MRI clinical implant experience starting February 2007 (928 leads implanted) *Exception of
24、 MRI Marker band and electrode coating,CapSureFix MRI SureScan Lead Model 5086 A Lead Designed for MRI Use The state-of-the-art 5086 lead is specifically designed and engineered for safety within an MRI environment The 5086 lead is based on the CapSureFix family of leads, which have been implanted i
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