POWERFULLY SIMPLE CARDIAC MONITORING SEEQ Mobile Cardiac Telemetry (MCT) System From the leaders who brought you Reveal LINQ ICM
MEDTRONIC CARDIAC DIAGNOSTIC & MONITORING SYSTEMS TRANSFORM Transform your ability to diagnose and treat even the most difficult-to-detect arrhythmias. 2 SEEQ Mobile Cardiac Telemetry System
WHAT MAKES POWERFUL MONITORING? TIMELY DIAGNOSIS PATIENT COMPLIANCE begins with devices that are patient-friendly simple, comfortable and unobtrusive. PATIENT COMPLIANCE CONTINUOUS MONITORING made possible by powerful and proven algorithms, is key to diagnosing complex cases. 1-7 CONTINUOUS MONITORING PROACTIVE SURVEILLANCE with remote monitoring allows timely detection and notification of significant events with clinically actionable reports. PROACTIVE SURVEILLANCE 3 SEEQ Mobile Cardiac Telemetry System
SIMPLE, POWERFUL, AND CONNECTED SOLUTIONS DESIGNED TO ENABLE TIMELY DIAGNOSIS AND ONGOING MANAGEMENT SEEQ Mobile cardiac telemetry system for short-term monitoring up to 30 days Reveal LINQ Insertable cardiac monitoring system for long-term monitoring up to 3 years 4 SEEQ Mobile Cardiac Telemetry System
POWERFULLY SIMPLE CARDIAC MONITORING SEEQ MCT System From the leaders who brought you Reveal LINQ ICM 5 SEEQ Mobile Cardiac Telemetry System
SHORT-TERM MONITORING MONITORING UP TO 30 DAYS The SEEQ MCT system is ideal for patients experiencing frequent symptoms that require short-term monitoring. 6 SEEQ Mobile Cardiac Telemetry System
PATIENT COMPLIANCE Wire free Water resistant Automatic Activation Turns on automatically Auto Capture and Patient Trigger No battery changes required 7 SEEQ Mobile Cardiac Telemetry System
CONTINUOUS MONITORING Slim profile allows for easy monitoring for up to 30 days * Automatic, wireless data collection and transmission Patients wore their SEEQ devices continually for 90% of the prescribed duration 1 * Reference the SEEQ MCT Instructions for use for usage parameters. 8 SEEQ Mobile Cardiac Telemetry System
PROACTIVE SURVEILLANCE Medtronic Monitoring center staffed 24/7 by trained cardiographic technicians to review patient data, interpret ECGs, generate reports and provide notification of clinically relevant events* * Based on programmed settings. 9 SEEQ Mobile Cardiac Telemetry System
POWERFUL CARDIAC MONITORING 5.8 DAYS Mean time to initial detection of clinically relevant arrhythmias 1 64% Detection rate of clinically relevant arrhythmias 1 TIMELY DIAGNOSIS PATIENT COMPLIANCE CONTINUOUS MONITORING PROACTIVE SURVEILLANCE 10 SEEQ Mobile Cardiac Telemetry System
THE SEEQ MCT SYSTEM SEEQ WEARABLE SENSOR Easy to apply, slim-profile sensor worn discretely under shirt or blouse. SEEQ TRANSMITTER Transmits data to Medtronic Monitoring Center 24/7. MEDTRONIC MONITORING CENTER Trained cardiographic technicians review ECG data and flag notable events. PHYSICIAN ACCESS TO CLINICAL REPORTS Clear and concise reports available online 24/7. 98% of patients achieve proper application. 8 90% patient compliance throughout duration of monitoring 1 64% detection rate of clinically relevant arrhythmias 1 5.8 Days mean time to initial detection of clinically relevant arrhythmias 1 11 SEEQ Mobile Cardiac Telemetry System
SYSTEM OVERVIEW SEEQ MCT Wearable Sensor Each sensor can be worn for 7.5 days up to 30 days. Adhesive-backed sensor is applied to chest. Sensor wirelessly communicates with the transmitter. The Wearable Sensor automatically captures events and/or patient can press the button to mark the event. 12 SEEQ Mobile Cardiac Telemetry System
SYSTEM OVERVIEW SEEQ MCT Transmitter Relays sensor data automatically via cellular signals to Medtronic Monitoring Center Rechargeable from standard electrical outlet Compact enough to tuck in purse or pocket Battery life of up to 12 hours Can send sensor data successfully to transmitter up to 30 feet away 13 SEEQ Mobile Cardiac Telemetry System
SYSTEM OVERVIEW Medtronic Monitoring Center The Medtronic Monitoring Center is a Medicare Certified Independent Diagnostic Testing Facility (IDTF) with two locations in Bala Cynwyd, PA and San Francisco, CA. TFs must meet a set of Performance Standards to obtain and maintain Medicare billing privileges 42 C.F.R. section 410.33(g). Center is staffed with Certified Cardiographic Technicians (cci-online.org). Medical Director oversight is provided by a Cardiac Electrophysiologist. 24/7/365 Hours of Operation All patient and clinical data are fictitious and for demonstration purposes only. 14 SEEQ Mobile Cardiac Telemetry System
ACTIONABLE REPORTS NOTIFICATION REPORT * DAILY REPORT ** END-OF-USE SUMMARY REPORT * Delivered ONLY when ECG meets Notification Criteria. ** Daily Reports are not part of the Default offering. Physicians must Opt-In to receive them. 15 SEEQ Mobile Cardiac Telemetry System
THE PATH TO A CONCISE CLINICAL REPORT HOW THE SEEQ MCT SYSTEM AND THE MEDTRONIC MONITORING CENTER REFINE ECG DATA SEEQ TRIGGER CRITERIA REPORTABLE CRITERIA Auto and Patient Triggers determine when ECGs are transmitted. ECGs may contain both abnormal or normal rhythms. Mostly a subset of the SEEQ trigger criteria. Determine which ECGs are included in Clinical Reports by the CMC. Automatic: Rate 130 bpm Rate 40 bpm Pause 3 sec Atrial Fibrillation VTach/Vfib Every 24 hrs, when no other Triggers Patient-Triggered: Driven by use of the Patient Trigger Button on the Wearable Sensor NOTIFICATION A subset of the Reportable Criteria. Determine when MDs also receive a Notification Report. 16 SEEQ Mobile Cardiac Telemetry System
THE PATH TO A CONCISE CLINICAL REPORT HOW THE SEEQ MCT SYSTEM AND THE MEDTRONIC MONITORING CENTER REFINE ECG DATA SEEQ TRIGGER CRITERIA ECGs Included in Clinical Reports REPORTABLE CRITERIA ECGs that ALSO drive NOTIFICATION CRITERIA Ventricular Fibrillation All are Reportable All Require Notification ICD Discharge All are Reportable All Require Notification Ventricular Tachycardia All 10 Beats, any Rate Wide Complex Tachycardia All 10 Beats, any Rate REPORTABLE CRITERIA PVCs > 6 PVCs per 45 sec ECG Not Urgent Sinus Bradycardia 30 bpm 30 bpm Sinus Tachycardia 160 bpm 180 bpm Supraventricular Tachycardia 130 bpm 150 bpm AND 30 sec 150 bpm 150 bpm AND 30 sec NOTIFICATION Atrial Fibrillation or Atrial Flutter 40 bpm Plus: New Onset Atrial Fibrillation or New Onset Atrial Flutter Plus: 1 ECG/day at a minimum (when available), irrespective of rate 30 bpm AND 30 sec When Notification Criteria are Met Pause 2.0 sec 3.0 sec 2nd Degree AV Block (Mobitz I) All are Reportable 50 bpm 2nd Degree AV Block (Mobitz II) All are Reportable All Require Notification Isolated 2nd Degree AV Block (2:1) All are Reportable 50 bpm Note: This is a summary of the default settings only. Details available on the US CMC Reportable and Notification Criteria Form. Default criteria can be modified upon Physician request. Criteria may be updated before initiation of PLE. High Degree AV Block All are Reportable All Require Notification 3rd Degree AV Block All are Reportable All Require Notification Patient Triggered ECGs All are Reportable When Notification Criteria are Met Technician's Discretion Any Any 17 SEEQ Mobile Cardiac Telemetry System
REFERENCES 1 Shinbane, et al. Wearable Wireless Arrhythmia Detection Patches: Diagnostic Arrhythmia Yield, Time to First Arrhythmia, and Patient Compliance. Presented at HRS 2013 (Poster #9813). 2 Sanna T, Diener HC, Passman RS, et al. Cryptogenic Stroke and Underlying Atrial Fibrillation (CRYSTAL AF). N Engl J Med. June 26, 2014;370(26):2478-2486. 3 Pürerfellner H, Pokushalov E, Sarkar S, et al. P-wave evidence as a method for improving algorithm to detect atrial fibrillation in insertable cardiac monitors. Heart Rhythm. September 2014;11(9):1575-1583. 4 Edvardsson N, Frykman V, van Mechelin R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. February 2011;13(2):262-269. 5 Krahn AD, Klein GJ, Yee R, Norris C. Final results from a pilot study with an implantable loop recorder to determine the etiology of syncope in patients with negative noninvasive and invasive testing. Am J Cardiol. July 1, 1998;82(1):117-119. 6 Krahn AD, Klein GJ, Yee R, Takle-Newhouse T, Norris C. Use of an extended monitoring strategy in patients with problematic syncope. Reveal Investigators. Circulation. January 26, 1999;99(3):406-410. 7 Krahn AD, Klein GJ, Yee R, Hoch JS, Skanes AC. Cost implications of testing strategy in patients with syncope: randomized assessment of syncope trial. J Am Coll Cardiol. August 6, 2003;42(3):495-501. 8 Engel, et al. Estimation of patient compliance in application of adherent mobile cardiac telemetry device. 33rd Annual International Conference of the IEEE EMBS, Boston, Massachusetts USA, August 30-September 3, 2011. 18 SEEQ Mobile Cardiac Telemetry System
IMPORTANT SAFETY INFORMATION This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. Consult instructions for use at this website. Manuals can be viewed using a current version of any major Internet browser. For best results, use Adobe Acrobat Reader * with the browser. For further information, please contact your local Medtronic representative and/or consult the Medtronic website. Medtronic SEEQ Mobile Cardiac Telemetry (MCT) System Indications The Medtronic SEEQ mobile cardiac telemetry (MCT) system is intended to continuously measure, record, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g., atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias, and conduction disorders. The SEEQ MCT system monitors, derives, and displays: ECG, Heart Rate. Contraindications Patients with known allergies or hypersensitivities to adhesives or hydrogel Patients with potentially life-threatening arrhythmias, or who require inpatient/hospital monitoring Warnings and Precautions Do not reapply the Wearable Sensor (it is meant for one-time use). For a complete list of precautions, please refer to the Instructions for Use document. See the device manual for detailed information regarding the indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. The SEEQ MCT system and the Medtronic Monitoring Center are provided by Medtronic Monitoring Inc., a wholly owned subsidiary of Medtronic. 19 SEEQ Mobile Cardiac Telemetry System
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