November 2016 POWERFULLY SIMPLE CARDIAC MONITORING. SEEQ External Cardiac Monitor (ECM) System. From the leaders who brought you Reveal LINQ ICM

Transcription

1 November 2016 POWERFULLY SIMPLE CARDIAC MONITORING SEEQ External Cardiac Monitor (ECM) System From the leaders who brought you Reveal LINQ ICM

2 TRADITIONAL HOLTER MONITORING TYPICALLY 1-2 DAYS NOT LONG ENOUGH CUMBERSOME WIRES LOW DIAGNOSTIC YIELD Holter records ECG for hours. If symptoms do not present daily or are infrequent, hours monitoring may not be enough to diagnose certain arrhythmias. Wearing a Holter Monitor, with its multiple wires, is not convenient for longer monitoring. Traditional Holter Monitors offer low diagnostic yield of 2%-13% 1 (depending on symptoms) 2

3 MEDTRONIC CARDIAC DIAGNOSTIC & MONITORING SYSTEMS TRANSFORM Transform your ability to diagnose and treat even the most difficult-to-detect arrhythmias. 3

4 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. 2-8 CONTINUOUS MONITORING PROACTIVE SURVEILLANCE with remote monitoring allows timely detection and notification of significant events with clinically actionable reports. PROACTIVE SURVEILLANCE 4

5 SIMPLE, POWERFUL AND CONNECTED SOLUTIONS DESIGNED TO ENABLE TIMELY DIAGNOSIS AND ONGOING MANAGEMENT CARDIAC DIAGNOSTICS AND MONITORING SEEQ External Cardiac Monitor System Reveal LINQ Insertable Cardiac Monitoring System 5

6 POWERFULLY SIMPLE CARDIAC MONITORING SEEQ ECM System From the leaders who brought you Reveal LINQ ICM 6

7 SHORT-TERM MONITORING MONITORING UP TO 30 DAYS The SEEQ ECM System is ideal for patients experiencing frequent symptoms that require short-term monitoring. 7

8 PATIENT COMPLIANCE Wire free Water resistant Automatic Activation Turns on automatically Auto Capture and Patient Trigger No battery changes required 8

9 CONTINUOUS MONITORING Slim profile allows for easy monitoring for up to 30 days* Each wearable sensor typically lasts 7.5 days Automatic, wireless data collection and transmission Patients wore their SEEQ devices continually for 90% of the prescribed duration 2 * Reference the SEEQ ECM Instructions for usage parameters. 9

10 PROACTIVE SURVEILLANCE Medtronic Monitoring center staffed 24/7 by trained cardiographic technicians to review data and provide notification of clinically relevant events* * Based on programmed settings 10

11 POWERFUL CARDIAC MONITORING 5.8 DAYS Mean time to initial detection of clinically relevant arrhythmias 2 64% Detection rate of clinically relevant arrhythmias 2 TIMELY DIAGNOSIS PATIENT COMPLIANCE CONTINUOUS MONITORING PROACTIVE SURVEILLANCE 11

12 THE SEEQ ECM 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. 9 90% patient compliance throughout duration of monitoring 2 64% detection rate of clinically relevant arrhythmias Days mean time to initial detection of clinically relevant arrhythmias 2 12

13 SYSTEM OVERVIEW SEEQ ECM Wearable Sensor Each sensor can be worn for 7.5 days up to 30 days Adhesive-backed sensor is applied to chest Wirelessly communicates with the transmitter The Wearable Sensor automatically captures events and/or patient can press the button to mark the event 13

14 SYSTEM OVERVIEW SEEQ ECM 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 14

15 SYSTEM OVERVIEW Medtronic Monitoring Center 24/7 hours of operation Staffed with: Highly trained Rhythm Analysis Technicians Medical Director 15

16 ACTIONABLE REPORTS Notification Report* End of Use Report * Delivered ONLY when ECG meets Notification Criteria. 16

17 THE PATH TO A CONCISE CLINICAL REPORT HOW THE SEEQ ECM SYSTEM AND THE MEDTRONIC MONITORING CENTER REFINE ECG DATA SEEQ Trigger Criteria Reportable Criteria Notification 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 A subset of the Reportable Criteria Determine when MDs also receive a Notification Report 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 17

18 THE PATH TO A CONCISE CLINICAL REPORT REPORTABLE/NOTIFICATION CRITERIA DEFAULTS: OUS ECGs Included in Clinical Reports REPORTABLE CRITERIA ECGs that ALSO drive NOTIFICATION CRITERIA Ventricular Fibrillation All are Reportable Always Notified ICD Discharge All are Reportable Always Notified Ventricular Tachycardia All 10 Beats, any Rate Trigger Criteria (Wearable Sensor) Wide Complex Tachycardia All 10 Beats, any Rate PVCs > 6 PVCs per 45 sec ECG Never Notified Sinus Bradycardia 35 bpm 35 bpm Sinus Tachycardia 180 bpm Never Notified Reportable Criteria Notify Supraventricular Tachycardia 130 bpm Never Notified Atrial Fibrillation or Atrial Flutter 150 bpm 40 bpm Plus: New Onset Atrial Fibrillation or New Onset Atrial Flutter Plus: 1 ECG/day at a minimum (when available), irrespective of rate Never Notified Pause 2.0 sec 3.0 sec 2nd Degree AV Block (Mobitz I) All are Reportable 40 bpm 2nd Degree AV Block (Mobitz II) All are Reportable Always Notified Isolated 2nd Degree AV Block (2:1) All are Reportable 50 bpm Note: Clinically relevant rhythms other than those explicitly listed (such as junctional or idioventricular rhythms) will be Reportable and may result in Notification by Technician discretion. High Degree AV Block All are Reportable Always Notified 3rd Degree AV Block All are Reportable Always Notified Patient Triggered ECGs All are Reportable When Notification Criteria are Met Technician's Discretion Any Any 18

19 REFERENCES 1 Rothman S, Laughlin J, Seltzer J, et al. The Diagnosis of Cardiac Arrhythmias: A Prospective Multi-Center Randomized Study Comparing Mobile Cardiac Outpatient Telemetry Versus Standard Loop Even Monitoring. J Cardiovasc Electrophysiol. March 2007; 18(3): Shinbane, et al. Wearable Wireless Arrhythmia Detection Patches: Diagnostic Arrhythmia Yield, Time to First Arrhythmia, and Patient Compliance. Presented at HRS 2013 (Poster #9813). 3 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): 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): 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): 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): 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): 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): 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,

20 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 External Cardiac Monitor (ECM) System Indications The Medtronic SEEQ external cardiac monitor (ECM) 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 ECM 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 and/or consult the Medtronic website at Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. The SEEQ ECM system and the Medtronic Monitoring Center are provided by Medtronic Monitoring Inc., a wholly owned subsidiary of Medtronic. 20

21 Medtronic 710 Medtronic Parkway Minneapolis, MN USA Toll-free in USA: Worldwide: medtronic.com UC b IE 2016 Medtronic. Cardiac Rhythm and Heart Failure Minneapolis, MN. All Rights Reserved. 11/2016 Medtronic, Medtronic logo, and Further, Together are trademarks of Medtronic. *Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 21