RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置課件

1、FDA approved for MRI useThe first pacing system to break the image barrierThe 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 CapS

2、ureFix MRI SureScan leads is required for use in the MRI environment.欣化檸范邪紉濾汞瘴滬欠釘丙趣漾豫顫菌傈夾魯暮扇故匈鉻診拋犯滌蔣筐RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置The First and Only Pacing SystemFDA Approved for MRI

3、UseSpecifically 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 cardiac care with MRI access.褐?jǐn)伋煌霕蛱罄谕备吠〈盗陚ヲ?yàn)毒朽唉宙揭夜銅鞏壹蜒邪寨垂賂笨淖雌RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝

4、置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Meeting the Need for MRIPacemaker Implants in an Aging PopulationThe number of pacemakers currently implanted in the United States is approximately 1.5 million1,2Elderly patients are the primary users of MRI: individuals over

5、age 65 are twice as likely to need an MRI compared to younger recipients.3Average Age of Pacemaker Patient13%Ages 25-6486%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

6、global strategic business report. San Jose, CA. 2002.珊扦伊省硯客積旨暈伎筑枯歧肉耍昂犢命祁老異椒屋資葷坤弘淋峪矛望柬RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Part of Comprehensive Patient CareNow, for the first time, you can im

7、plant a state-of-the-art pacing system to provide proven cardiac care AND MRI access when your patients need itNumber of Comorbidities in Pacemaker PatientsGiven that 85% of all pacemaker patients have one or more comorbidities, facilitating comprehensive multispecialty care is important in todays e

8、nvironmentMedical and Surgical Specialties Rely on MRI for DiagnosisYour choice can affect their decisions and diagnostic capabilities15%0 comorbidities30%1 comorbidity28%2 comorbidities27%3 or morecomorbiditiesOpthalmologyOtolaryngologyNeurosurgeryNeurologyCardiothoracic SurgerySurgical OncologyNep

9、hrologyGynecologic OncologyUrologyRheumatologyOncologyRadiation OncologyInterventional RadiologyGastrointestinal SurgeryOrthopedic SurgeryVascular Surgery85%1 1 or more comorbidities1 Kalin R, Stanton MS. PACE. 2005;28:326-328.爽賤摸桐差擄十遇萎勵三琢玉馳澆熙醚戚餞綴熬炙焦宙滄矩拍楓代臂元舞RevoMRISureScanPacemaker-MedtronicCRDMDev

10、ice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Prevalence of Common Comorbiditiesin the Pacemaker Patient PopulationThe Prevalence of Common Comorbidities Increases Rapidly Over Age 65.1-3MRI Is the Gold Standard Diagnostic Tool forNeurologis

11、ts, Oncologists, and Orthopedic Surgeons,Whose Patients Are Often Over 65 Years of Age.4MRI 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 device5The Most Common Reaso

12、ns for MRI Referral AreMusculoskeletal and Neurological Symptoms.6 Medicare records show that in patients 65 years of age withan implanted pacemaker:34% have spine and intervertebral disc disease7 36% have chronic pain of wrist, foot, ankle, or elbow714% suffer from injury or trauma to the spine, kn

13、ee, or shoulder71 National Cancer Institute April 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;

14、41:778-799.3 American Heart Association. Heart Disease 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 Kali

15、n R, Stanton MS. PACE. 2005;28:326-328.6 Medical Imaging Survey, 2009.7 Medicare Fee-for-Service Review, 2007.艙睡欠棋董越霸避恿氰瞻精揀吶桌訣頻塊瓊奠敗燎賣酥鄖橢琵絮分宴灘挽RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置 FieldImpact

16、StaticGradientRFLead HeatingThe conductive pacing lead acts as an antenna, picking up radiofrequency energy. A portion of this energy is dissipated as heat in the cardiac tissue near the tip electrode.Tissue damage may affect pacing therapy.Unintended Cardiac StimulationThe gradient and radiofrequen

17、cy fields will induce voltages in pacemaker leads that will be applied to the pacing lead electrodes. If these voltage pulses are large enough, they may directly stimulate the heart.May lead to a single or intermittent stimulation, or sustained tachycardia.Device InteractionsThe gradient, radiofrequ

18、ency, and static fields may adversely affect the electrical operation of the pacemaker system if its operation is not protected from the effects of those fields.Pacemaker malfunction or failure may affect pacing therapy.Hazards and Risks of MRI with Current Pacing SystemsSince 2008, the safety and r

19、isk 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 following16:1Naehle CP, et al. Pacing Clin Electrophysiol. 2009;32:1526-1535. 2Goldsher D, et al. Pacing Clin Electrophysiol. 2009;32:1355-1356.3Gimbel JR. Eu

20、ropace. 2009;11:1241-1242.4Naehle CP, et al. J Am Coll Cardiol. 2009;54:549-555. 5Roguin A. J Am Coll Cardiol. 2009;54:556-557. 6Mollerus M, et al. Pacing Clin Electrophysiol. 2008;31:1241-1245. 7Pulver AF, et al. Pacing Clin Electrophysiol. 2009;32:450-456. 8Nordbeck P, et al. Magn Reson Med. 2009;

21、61:570-578. 9Sutton R, et al. Trials. 2008;9:68.10 Naehle CP, et al. Radiology. 2008;249:991-1001.11Calcagnini G, et al. J Magn Reson Imaging. 2008;28:879-886. 12Dyrda K, Khairy P. Expert Rev Cardiovasc Ther. 2008;6:823-832. 13Gimbel JR. Pacing Clin Electrophysiol. 2008;31:795-801. 14Nordbeck P, Bau

22、er WR. Dtsch Med Wochenschr. 2008;133:624-628.Article in German.15Tandri H, et al. Heart Rhythm. 2008;5:462-468. 16Roguin A, et al. Circulation. 2004;110:475-482. 17Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval.MR Conditional Risk Informati

23、on A complete SureScan pacing system including a Revo MRI SureScan IPG and two CapSureFix MRI SureScan leads is required for use in 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

24、the patient to be safely scanned while the device continues to provide appropriate pacing Refer to the Revo MRI Pacing System Conditions for Use located in the device manuals prior to scanning a patient. Consult Medtronics website at or call Medtronic at 1 (800) 328-2518.錫碗豆波烽謂旺繕兒倫入恐肯恰制稠盂晌吊擂巨胯掛斗漲頃攤伏

25、潛肋衰措RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Specifically Engineered for MRI SafetyDevice Design SolutionsInput circuits optimizedCircuit design immune to interferenceSureScan Pacing Mode Asynchr

26、onous pacing High pacing outputsThe 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 manualThe implanted system must consist solely of a Medtronic Re

27、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 screenAutomatic testing ensures only appropriate battery and impedance data ar

28、e collected during MRIDedicated 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所廓集桓彭更儡津嚼持薪蟲吝欲苗紙拋不處蚤戳滾沾汽延攪鐘茁疫獸嚎塢RevoMRISureScanPacemaker-MedtronicCRDMDevi

29、ce：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Specifically Engineered for MRI SafetyLead Heating Design SolutionLead inner conductor coil design mitigates lead heating 4 filar to 2 filar increases inductance and reduces heatingMaterials ident

30、ical to 5076*Model 5086MRI lead flex testing Connector/body Lead bodyModel 5086MRI clinical implant experience starting February 2007 (928 leads implanted)*Exception of MRI Marker band and electrode coatingCapSureFix MRI SureScan Lead Model 5086 A Lead Designed for MRI UseThe state-of-the-art 5086 l

31、ead 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 in more than 1 million patients worldwide thats 2.5 million leads, with 99.5% reliabilityEasily Identifiable, Radiopaque Icon Confirms

32、SureScan Device ImplantLead HeatingModel 5076 versus Model 5086 MRI the x-axis represents 50 anatomically relevant lead paths the results demonstrate significant variability in lead tip heating as a function of the lead path overall the 5086 MRI lead heats approximately 3 times less than the 5076 fo

33、r most lead paths仰溜痞禿瀾撂膊蟹帶貸累健氫撂抗碾翹玻箱筷惜者騁監(jiān)胰評鴿康僑跪苫贏RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Preclinical Research Demonstrates the Safety of Revo MRI Pacing System1Testing SummaryExtensive preclinic

34、al evaluation was based on clinically relevant as well as worst-case scan conditions, using in vitro (bench) testing, in vivo (animal) testing, and computer simulations (modeling).MRI-Induced Lead HeatingSimulations in Human Body Models Using Different Lead Combinations Human body models encompassed

35、 2nd to 97th percentile of all human bodies, with ten different lead paths Over 400,000 different lead/body combinations were analyzed to derive a minimal probability of a 0.5 V thresholdHuman Body LibraryLead Paths1 Magnetic Resonance Imaging (MRI) Equipment a global strategic business report, Glob

36、al Industry Analysts, Inc. San Jose, CA. 2002.限屹搓履帕讀肅馭捐賽貪請仇撩亂緞馮沂輸屁直序嗓捧牟尿瑣鱗缽暮僵寓RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置MRI-Induced Unintended Cardiac Stimulation (UCS)Analysis combined a predicti

37、on for the induced voltage pulse widths and amplitudes, and an in-vivo canine study to evaluate the stimulation threshold to these pulsesThe risk of reaching the gradient stimulation range is 1/1,000,000, which remains outside the capture rangeResults confirmed that patient risk from UCS is at an ac

38、ceptable levelGradient Stimulation Strength Duration Curve忿扼刑枯敢壩懼釘輝一盎鴉靖控富汪弘庶輿償像石怎豪暈詛管遵洋惱稠流RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Study DesignMulticenter, randomized, controlled clinical trial d

39、esigned to evaluate the safety of the Revo MRI SureScan Pacing System, including any MRI-related complications, as well as to analyze pacing capture thresholds and sensing amplitude464 patients received a SureScan pacing system and were then randomized to elective MRI or no MRI, approximately 9-12 w

40、eeks post-implantMRI imaging intended to represent commonly used, clinically relevant scansMethods Visit ScheduleClinical Trial Demonstrates the Safetyof Revo MRI SureScan11 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval. 汐鶴渤盾領(lǐng)冒揉刻駐雖賤紹翔怠翟貯梨筷舌

41、匯劑繳殿化忙皮靛阮蘿霞悲憫RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Clinical Trial Demonstrates the Safetyof Revo MRI SureScan1Key Results100% were free of MRI-related complications (n = 211, P 0.001)No sustai

42、ned atrial or ventricular arrhythmias, no asystole, no pacemaker output inhibition, and no electrical resets in the group receiving MRI Minimal changes in pacing capture thresholds, as shown on the following chartPrimary Effectiveness End Point: Atrial and Ventricular Capture ThresholdThreshold chan

43、ges pre-MRI/control visit to 1-month post-MRI/control visit1 Medtronic, Inc. EnRyhthm MRI SureScan Pacing System Clinical Report, in support of FDA premarket approval. 蜒誤回丫吸利鵲命漫抹左裔叢件譽(yù)拾咽芹睬陰構(gòu)化嫁父淀嘯汕睜獅午猴黎RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-Me

44、dtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Builds Upon Medtronic InnovationsMVP Managed Ventricular Pacing Exclusive technology that uses atrial pacing (AAIR) primarily, with DDD(R) pacing only when necessary MVP reduces unnecessary RV pacing by 99%1ACC/AHA/HRS guidelines2 state the need to reduc

45、e unnecessary pacing as much as possible. The following studies support the guidelines:MOST3: Every incremental 1% of unnecessary VP increases the risk for heart failure hospitalizations by 5.4%, and for AF, by 1%.Danish II4: Even with long AV delays, the risk of AF doubles with DDD(R) pacing compar

46、ed to AAI(R) with DDD(R) backup.Gardiwal5: Patients with 72% RV pacing are at increased risk for VT/VF. Medtronic CareLink Network* The leading Internet-based, remote monitoring service for implanted devices6Serving nearly 500,000 patients in 3,000 clinics in the United States* Not all devices are a

47、vailable on the CareLink Network1 Gillis AM, et al. Heart Rhythm. 2005. Abstract AB21-1.2 Epstein AE, et al. J Am Coll Cardiol. 2008;51:e1-62.3 Sweeney MO, et al. Circulation. 2003;10:2932-2937.4 Nielsen JC, et al. J Am Coll Cardiol. 2003;42:614-623.5 Gardiwal A, et al. Europace. 2008;10:358-363.6 M

48、edtronic CareLink Metrics Database.擠幢潤馭第唁赦咎澗藥汾攀擬鑄詩善巖雪扭曬澡裕拼蝴探萊拙氫銻束曾潰RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Revo MRI Pacing System Conditions for UseA complete SureScan pacing system including a

49、Revo MRI SureScanIPG and two SureScan leads is required for use in the MRI environment.Any other combination may result in a hazard to the patient during an MRIscan. The SureScan feature must be programmed to On prior to scanning apatient according to the specified conditions for use.Cardiology requ

50、irements:Patients and their implanted systems must be screened to meet the following requirements: No previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors No broken leads or leads with intermittent electrical contact, as confirmed by lead impedance hist

51、ory A SureScan pacing system that has been implanted for a minimum of 6 weeks A SureScan pacing system implanted in the left or right pectoral region Pacing capture thresholds of 2.0 volts (V) at a pulse width of 0.4 milliseconds (ms) A lead impedance value of 200 ohms () and 1,500 No diaphragmatic

52、stimulation at a pacing output of 5.0 V, and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when the MRI SureScan is onRadiology requirements:Horizontal, cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T)

53、 must be usedGradient systems with maximum gradient slew rate performance per axis of 200 Teslas per meter per second (T/m/s) must be usedThe scanner must be operated in Normal Operating mode: The whole-bodyaveraged specific absorption rate (SAR) must be 2.0 watts per kilogram (W/kg) The head SAR mu

54、st be 3.2 W/kgThe patient must be positioned within the bore such that the isocenter (center of the MRI bore) is superior to the C1 vertebra or inferior to the T12 vertebraProper patient monitoring must be provided during the MRI scan. The methods include visual and verbal contact with the patient,

55、electrocardiography, and pulse oximetry (plethysmography).Training requirements: A health professional who has completed cardiology SureScan training must be present during the programming of the SureScan feature A health professional who has completed radiology SureScan training must be present dur

56、ing the MRI scan咨椰一躍霖飛絳醫(yī)窿郝躺姥汁框俱近倔鮑疆呈咯聞彈撞新明圣頰甭跺應(yīng)真RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置RevoMRISureScanPacemaker-MedtronicCRDMDevice：revoMRIsurescan起搏器-美敦力CRDM裝置Brief StatementThe Revo MRI SureScan pacing system is MR Conditional and as such is designed to allow pati

57、ents to undergo MRI under the specified conditions for use.IndicationsThe Revo MRI SureScan Model RVDR01 IPG is indicated for use as a system consisting of Medtronic Revo MRI SureScan IPG implanted with two CapSureFix MRI SureScan 5086MRI leads. A complete system is required for use in the MRI envir

58、onment.The Revo MRI SureScan Model RVDR01 IPG is indicated for the following:Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activityAccepted patient conditions warranting chronic cardiac pacing include:Symptomatic paroxysmal or permanent sec

59、ond- or third-degree AV blockSymptomatic bilateral bundle branch blockSymptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disordersBradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmiasThe dev

60、ice is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include:Various degrees of