New markets in clinical diagnoses and clinical studies are emerging as prices decrease and technology creates more advanced devices. Smart phones include the technology to implement a core device used for m-health implementations. Unit functions are being extended from direct arrhythmia symptom analysis to sleep studies and clinical drug efficacy studies creating significant growth opportunity.

According to Susan Eustis, lead author of the WinterGreen Research team that prepared the cardiac event ambulatory monitors and recorders market research study, “Shortness of breath is a common symptom of cardiac disease. It is frequently misdiagnosed as a respiratory symptom or ignored by patients and is not even considered a cardiac symptom when the clinician is making a diagnosis. Cardiac event ambulatory monitors can detect arrhythmias and get people to treatment faster before it is too late to correct congestive heart failure.”

Early treatment is essential and the technology is a vital aid in providing that treatment. Hospitals and clinicians will have increased access to devices as insurers realize the value of detecting and treating cardiac disease early. Sleep studies and clinical drug efficacy study opportunities are creating significant growth opportunity.

Cardiac Event Recording and monitors are evolving as a services industry. Patients do not pay directly for units, they are provided by a clinician and the clinician is reimbursed by CMS in the US as a fee for service. In this manner the vendors participate in the services market. The cardiac event recording services industry is fragmented and characterized by a large number of smaller regional hospital and home care service providers.

Consideration of Cardiac Event Recorder Market Forecasts indicates that markets at $197.8 million in 2012 will reach $862.7 million by 2018. Growth comes as more emphasis is put on early diagnosis and prevention of disease. Heart failure patients participating in home based programs get called back from nurse within 20 minutes of transmitting readings. This is similar to the response time available in a hospital and positions products in the large and growing telemedicine market space.

For a patient that has arrhythmia and a device detects symptoms, there is the ability to take life saving action. Quick response brings the matter to the attention of the clinician often without patient involvement, helping better serve the patient. Advice can be rendered as to how and why weight fluctuation is a issue and how control of disease is based on lifestyle and diet. Rapid weight gain can indicate fluid retention and a worsening of cardiac function.

This study illustrates the cardiac event recording market driving forces and provides the market shares and consideration of market size and number of recorders prescribed or used. It describes monitoring services used and services provided to subscribers, reimbursement by insurance carriers. The principal competitive factors that impact the success of cardiac monitoring solutions are addressed in the comprehensive market study:

Table Of Contents

Table of Contents

Executive Summary

Cardiac Event Recording Market Driving Forces
Cardiac Event Recorder Market Shares
LifeWatch V, an Android-Based Smartphone CardioNet
Cardiac Event Recorder Market Forecasts

1. Cardiac Event Monitoring Market Description
and Market Dynamics

1.1 Cardiac Event Monitoring
1.1.1 Cardiac Arrhythmia Definitions
1.1.2 Atrial Fibrillation
1.1.3 Ventricular Tachycardia.
1.1.4 Syncope
1.1.5 Traditional Arrhythmia Monitoring Technologies
1.2 Cardiac Event Monitors
1.2.1 Manual-Trigger Loop Event Monitors
1.2.2 Cardiac Event Recorders
1.3 Holter Monitors
1.4 Remote Monitoring as Standard of Care
1.4.1 Telemonitoring Systems Premise
1.4.2 Sedentary Get Exercise And Heart Failure Patients
Pay Attention To Swelling In Their Feet, Ankles Or Legs
1.4.3 Telemonitoring Systems Improve Home Health Care
1.4.4 Vital Signs And Health Status Are Measured Daily
1.4.5 Telemonitoring at Home
1.5 Telemedicine
1.5.1 Nursing Stations
1.5.2 Telemedicine Services
1.5.3 Service Provider Adoption of Tele-Monitoring
1.5.4 Telemedicine Delivery Mechanisms
1.5.5 Telemedicine Point-To-Point Connections
1.5.6 High Definition Video Communication
1.6 Telemonitors Customized To Meet Individual Needs
1.7 US Makes Telemedicine Priority
1.7.1 Federal Funding for Telemedicine
1.7.2 US Telemedicine Medicare -
1.7.3 US Veterans Health Administration (VA) Use of
Telemonitoring
1.7.4 Telemonitoring Demonstrates Positive Results In Improving Health Care And Reducing Costs Of Veterans
1.7.5 US VA Tele-monitoring Targeted Innovation:
1.8 Tele-Monitor Devices
1.8.1 Customizing Tele-Monitors
1.8.2 Intel Health Care Management Security
1.9 Telemonitoring Research
1.9.1 New England Journal of Medicine Research
1.9.2 NEJM Has Published Several Letters That Critique The Study
1.9.3 25 Studies of Remote Monitoring Of Patients With Chronic Heart Disease
1.9.4 Bosch Health Buddy Desktop Research
1.10 Physician Notification on CHF
1.11 US Patient Protection and Affordable Care Act
1.12 Federal, State, Local, And Foreign Laws Compliance
1.12.1 Government Regulation of Medical Devices
1.12.2 Before And After A Medical Device Is Commercially Distributed, Ongoing Responsibilities Under FDA Regulations
1.12.3 Tele-monitoring Third-Party Reimbursement
1.13 Health Information Privacy HIPAA Requirements
1.13.1 HIPAA Enforcement
1.13.2 OCR Responsible For Enforcing HIPAA Privacy and Security Rules
1.14 Postacute Care Co-ordination: Healthcare Reform Readmission Penalties
1.14.1 Federal Crimes Under The Health Insurance Portability and Accountability Act HIPAA
1.15 Partners Mass General Cardiologist Program for High Risk
Heart Failure Patients

2. Cardiac Event Ambulatory Monitors and
Recorders: Market Shares and Forecasts

2.1 Cardiac Event Recording Market Driving Forces
2.2 Cardiac Event Recorder Market Shares
2.2.1 LifeWatch V, an Android-Based Smartphone
2.2.2 CardioNet
2.2.3 CardioNet Monitoring
2.2.4 CardioNet Central Monitoring Station/Data Transmission Network
2.2.5 CardioNet Monitoring Physician Notification
2.2.6 CardioNet Monitoring Other Arrhythmia Monitoring Services
2.2.7 CardioNet Future Uses for MCOTâ„¢ Monitoring Platform
2.2.8 CardioNet Monitoring Advanced Technology
2.2.9 CardioNet Monitoring Wireless Data Transmission Network
2.2.10 CardioNet Monitoring Research and Development
2.2.11 Philips
2.2.12 Savi CardioPAL -
2.2.13 iRhythm / Zio Event Card
2.2.14 Reka
2.2.15 REKA E100 Received FDA Clearance
2.3 Cardiac Event Monitor Market Shares, Units and Dollars, Worldwide
2.4 Cardiac Event Recorder Market Forecasts
2.5 US Veterans Administration (VA) Tele-monitoring of Congestive Heart Failure (CHF)
2.5.1 Congestive Heart Failure
2.5.2 Diabetes Chronic Illness Numbers
2.5.3 Incidence of Chronic Disease
2.5.4 Chronic Diseases Account For Two-Thirds Of Worldwide Healthcare Spending
2.5.5 Surgical Procedures::US and Worldwide
2.6 Total Number Of Surgical Procedures And Market Penetration of Surgical Robots
2.6.1 Clinical Staff / Patient Ratios: Physician Shortages
2.6.2 Telemonitoring Market Driving Forces
2.6.3 Measures of Tele Monitoring Effectiveness
2.6.4 Home Patient Monitoring Supports Patient Education
2.6.5 Wireless Telemonitoring Devices
2.6.6 Implantation of Patient-Activated Cardiac Event Recorder
2.6.7 Medical Conditions Treated by Cardiac Event Recorders
2.7 Telemedicine Market Driving Forces
2.8 Cardiac Event Recording Pricing
2.9 Cardiac Event Recorder Regional Market Segments

3. Cardiac Event Ambulatory Monitors and
Recorders: Product Description

3.1 Philips Event Recorder Monitors
3.1.1 Philips CardioCare Cellular Event Monitor
3.1.2 Philips RT20 Event Monitor -
3.1.3 Philips ER910 Event Monitor
3.2 CardioNet
3.2.1 CardioNet FDA Marketing Clearance
3.2.2 CardioNet
3.3 Card Guard / Instromedix
3.3.1 Instromedix Heartrak Smart
3.4 eCardio
3.4.1 eCardio Billing
3.5 iRhythm / Zio Event Card
3.6 Reka e100
3.7 Cardiac Event Recorder Services
3.7.1 Philips CardioCare Cellular Event Monitoring Service
3.8 Lifewatch Services
3.8.1 LifeWatch V, an Android-Based Smartphone
3.9 Defibrillator / Event Monitor Devices
3.9.1 Philips HeartStart MRx Monitor/Defibrillator for EMS

4. Cardiac Event Monitor Technology

4.1 Cardiac Event Monitor Lead Placement
4.2 Reimbursement and Code Chart
4.2.1 Codes For Billing And Reimbursement For Holter Monitoring, Cardiac Event Monitoring, and Pacemaker Monitoring in the United States
4.2.2 US CMS Medicare Health Net, Inc. Considers The Use Of Implantable Loop Recorder Cardiac Event Monitors
4.2.3 Implantation of Cardiac Event Recorder
4.2.4 Patient-Activated Cardiac Event Recorder Primary Diagnosis Allowed
4.2.5 Cardiac Event Monitors That Are Deemed Not
Medically Necessary
4.3 Cardiac Event Recorder Validation and Use Cases
4.3.1 Event Monitor Indications For Use
4.4 Event Monitoring Studies
4.4.1 Scripps Telemonitoring
4.4.2 Scripps iRhythm / Zio Event Card
4.4.3 Kaiser Telemonitoring Study Shows Improvement in Patients
4.4.4 Lifewatch Case Studies
4.4.5 LifeStar ACT Case Study
4.4.6 Viterion Home Health Outcomes in a CHF Population:
4.4.7 CardioNet Monitoring Randomized Clinical Study
4.4.8 CardioNet's Monitoring Experience
4.4.9 CardioNet Monitoring Other Studies
4.4.10 iRhythm Zio Event Recorder Customer Testimonial
4.5 Government Regulation
4.5.1 U.S. Food and Drug Administration.
4.5.2 Health Care Fraud and Abuse
4.5.3 The Patient Protection and Affordable Care Act.
4.5.4 Health Insurance Portability and Accountability Act of 1996 (HIPAA).
4.5.5 Medicare
4.5.6 Facilities
4.5.7 Event Monitor Vendor Environmental Regulation

5. Cardiac Event Ambulatory Monitors and
Recorders: Company Profiles

5.1 ATandT
5.1.1 ATandT Revenue
5.1.2 ATandT Wireless
5.1.3 ATandT Services and Products
5.1.4 ATandT Voice Service -
5.1.5 ATandT Innovative Data Services
5.1.6 ATandT Business Customers
5.1.7 ATandT Data/Broadband
5.1.8 ATandT Business Secure Mobile Threats
5.1.9 ATandT Mobile Security
5.1.10 ATandT and VRI To Offer Managed Remote Telemonitoring Service
5.2 Biotronik
5.2.1 Biotronik Electrotherapy
5.2.2 Biotronik Vascular Intervention
5.2.3 Biotronik CHF Study
5.3 Cardionet
5.3.1 American Medical Association ("AMA") Has Established Billing Codes
5.3.2 CardioNet Strategy
5.3.3 Cardionet Revenue
5.3.4 Cardionet Relationship With nPhase, formerly Qualcomm
5.3.5 Cardionet, Inc. To Acquire Cardiocore Lab, Inc. For $23.5 Million
5.3.6 CardioNet Monitoring Second Quarter 2012 Revenue
5.3.7 CardioNet, Settled The Patent Infringement Action Brought by LifeWatch Services, Inc., and Card Guard Scientific Survival, Ltd. (“Lifewatch”)
5.4 eCardio
5.5 iRhythm / Zio
5.6 LifeLine Medical
5.7 Lifewatch
5.7.1 Lifewatch / Card Guard / Instromedix
5.7.2 LifeWatch / Lifestar ACT Products
5.7.3 LifeStar ACT Ex Functions
5.7.4 LifeWatch Services
5.7.5 LifeWatch and Blue Shield of California
5.7.6 LifeWatch Call Center in San Francisco, California
5.7.7 LifeWatch joint development with U.S. Medical Technology Developer Ansar Monitoring Services
5.7.8 LifeWatch First Quarter Of 2012 Revenues
5.7.9 Lifewatch Key Revenue Figures per Quarter
5.8 Philips
5.8.1 Philips Revenue
5.8.2 Philips
5.8.3 Phiips Visicu
5.8.4 Philips Addresses Healthcare Landscape
5.8.5 Philips/Respironics Monitoring Solution Powered By Cinterion TC65i:
5.8.6 Philips Sales
5.8.7 Philips Healthcare
5.8.8 Royal Philips Electronics / Respironics
5.8.9 Philips Respironics
5.8.10 Philips Respironics
5.9 Reka
5.10 VRI
5.10.1 VRI Digi Pal
5.10.2 VRI partnership with Robert Bosch Healthcare
5.10.3 VRI Digi Pal
5.10.4 VRI
5.11 Windstream
5.12 Selected Providers for Emergency Medical Care Monitoring



List of Tables and Figures

Cardiac Event Ambulatory Monitors And Recorders: Executive Summary

Table ES-1
Cardiac Event Recording Market Driving Forces
Figure ES-2
Cardiac Event Recording Market Shares, Dollars, Worldwide, 2012
Table ES-3
Cardiac Event Monitor Market Shares, Dollars, Worldwide, 2012
Figure ES-4 ES-6
LifeWatch V, an Android-Based Smartphone 6
Figure ES-5
Cardiac Event Recording Market Shares, Dollars, US, 2012
Figure ES-6
Cardiac Event Recorder Market Forecasts, Dollars,
Worldwide, 2013-2018

Cardiac Event Ambulatory Monitors And Recorders: Market Description and Market Dynamics

Figure 1-1
Remote Monitoring as Standard of Care
Table 1-2
Telemedicine Nursing Stations Typical Telemonitoring Questions
Table 1-3
Remote Patient Monitoring Device Uses
Table 1-4
Clinical Assessment and Response to Alert Provided by Telemonitor
Table 1-4 (Continued)
Clinical Assessment And Response To Alert Provided By Telemonitor
Table 1-5
Clinical Assessment And Actions Taken To Alert Provided By Telemonitor
Table 1-6
Telehealth Solutions Benefits
Table 1-7
Monitoring Used To Take Measurements In Homecare Settings
Table 1-8
Monitoring Measurement Functions In Homecare Settings
Table 1-9
Bosch Recommendations for Innovation Funded By The VA
Table 1-10
Intel Health Guide Functions
Table 1-11
Intel Health Care Management Suite of Software Tools
Table 1-11
NEJM Letters That Critique The Telemonitoring Study
Table 1-12
Physician Notification on CHF Using “SBAR”
Table 1-13
US Healthcare Coverage Legislation Functions
Table 1-14
FDA Enforcement Actions And Remedies
Table 1-15
HIPAA Information Covered entities
Table 1-16
HIPAA Information That Needs to Be Private
Table 1-17
HIPAA Information Sharing by Health Care Providers
Table 1-18
HIPAA Information Sharing Prohibitions
Table 1-19
HIPAA Information Managed via Court Order
Figure 1-20
HIPAA Privacy and Security Rule and Compliant Process

Cardiac Event Ambulatory Monitors And Recorders: Market Shares and Market Forecasts

Table 2-1
Cardiac Event Recording Market Driving Forces
Figure 2-2
Cardiac Event Recording Market Shares, Dollars, Worldwide, 2012
Table 2-3
Cardiac Event Monitor Market Shares, Dollars, Worldwide, 2012
Figure 2-4
Cardiac Event Recording Market Shares, Dollars, US, 2011
Table 2-5
Cardiac Event Monitor Market Shares, Dollars, US, 2011
Table 2-6
CardioNet Monitoring Device Product Enhancements
Table 2-7
Cardiac Event Monitor Market Shares, Units and Dollars,
Worldwide, 2011
Table 2-8
Cardiac Event Monitor Market Shares, Units and Dollars, US, 2012
Figure 2-9
Cardiac Event Recorder Market Forecasts, Dollars,
Worldwide, 2012-2018
Figure 2-10
Cardiac Event Recording Vendor Portion of Patient Services
Market Forecasts Dollars, Worldwide, 2013-2018
Table 2-11
Cardiac Event Recording Device and Patient Services Market
Forecasts Units and Dollars, Worldwide, 2013-2018
Table 2-12
Cardiac Event Recording Device and Patient Services Market
Forecasts Units and Dollars, US, 2013-2018
Figure 2-13
Congestive Heart Failure (CHF) Patients Worldwide, Forecasts,
Number, 2012-2018
Figure 2-14
Diabetes Patients Worldwide, Forecasts, Number, 2013-2018
Table 2-15
Number of Patients with Disease Conditions Requiring
Wheelchairs, By Diagnosis, Number, Worldwide, 2013-2018
Table 2-16
Total Number Of Surgical Procedures Performed In Us:
Table 2-17
Total Number Of Surgical Procedures Performed Worldwide:
Table 2-18
US and Worldwide Robotic Surgery Target Procedures:
Table 2-19
Actual Intuitive Surgical Surgeries: Prostate
Table 2-20
Actual Intuitive Surgical Surgeries: Hysterectomy
Table 2-21
Titan Medical Target Robotic Surgeries, Worldwide
Table 2-22
Robotic Surgeries Possible by Medical Condition
Table 2-23
Telemonitoring Market Driving Forces
Table 2-24
Tele-Monitoring Critical Issues Addressed
Table 2-25
Medical Conditions Treated by Cardiac Event Recorders
Table 2-26
Factors Likely To Create Shift To Event Monitoring
Table 2-27
Telemedicine Adoption Rate Issues And Concerns
Figure 2-28
Telemedicine Market Factors
Figure 2-29
Cardiac Event Monitor Regional Market Segments, Dollars, 2012
Table 2-30
Cardiac Event Recorder Regional Market Segments, 2012

Cardiac Event Ambulatory Monitors And Recorders: Product Description

Figure 3-1
Philips CardioCare Cellular Event Monitor
Figure 3-2
Philips RT20 Event Monitor -
Figure 3-3
Philips ER910 Event Monitor -
Table 3-4
Philips ER910 Event Monitor -
Table 3-5
CardioNet Monitoring Indications for Use
Table 3-6
CardioNet Contraindicatios For Use In The Following Patients:
Figure 3-7
CardioNet Cardiac Event Recorder Services
Figure 3-8
Instromedix Cardiac Event Recorders
Table 3-9
eCardion Event Monitors
Figure 3-10
eCardio Device
Table 3-11
REKA E100: Cardia Event Recorder Benefits
Table 3-12
Philips Services Implementation
Table 3-13
Philips HeartStart MRx Monitor/Defibrillator Features
Table 3-14
Philips HeartStart MRx Monitor/Defibrillator Rugged and
Reliable Functions
Table 3-15
Philips HeartStart MRx Monitor/Defibrillator Intuitive And
Ease Of-Use Features
Figure 3-16
Philips HeartStart MRx Monitor/Defibrillator

Cardiac Event Ambulatory Monitors And Recorders: Technology

Figure 4-1
Cardiac Event Monitor Lead Placement
Table 4-2
CMS Medicare program Cardiac Event Monitor Requirements
Table 4-3
Codes For Billing And Reimbursement for Holter Monitoring,
Cardiac Event Monitoring, and Pacemaker Monitoring in the
United States
Table 4-4
Cardiac Event Recorder Use Cases
Figure 4-5
Scripps Lifewatch Telemonitoring Device Array
Table 4-6
Lifewatch Case Study: 83 Year Old Female
Table 4-7
Sample Studies of LifeStar ACT Syncope Patient Presentations and
Solutions (Age 85)
Table 4-8
Sample Studies of LifeStar ACT Syncope Patient Outcome
(Age 85)
Table 4-9
Sample Studies of LifeStar ACT Heart Block Patient
Presentations and Solutions (Age 55)
Table 4-10
LifeStar ACT Monitor For Following Conditions

Cardiac Event Ambulatory Monitors And Recorders: Company Profiles

Table 5-1
ATandT Mobile Security Benefits
Table 5-2
Biotronik Electrotherapy Devices
Table 5-3
Biotronik Electrotherapy Devices
Table 5-4
LifeWatch LifeStar ACT III Platinum Functions
Table 5-5
LifeStar ACT Ex Functions
Table 5-6
LifeStar ACT Ex Standard Features
Table 5-7
LifeStar ACT Enhanced Daily Reporting Features
Table 5-8
Philips Positions To Simplify Global Healthcare
Delivery For The Long Term
Table 5-9
Philips Healthcare Delivery Product Positioning
Figure 5-10
Philips Healthcare Positioning
Figure 5-11
Philips Healthcare Equipment Order Intake Trends
Figure 5-12
Philips Revenue Market Segments
Figure 5-13
Philips Employee, Manufacturing, and Research Profile
Figure 5-14
Philips Continuing Sales Growth in Emerging Markets
Figure 5-15
Philips Gaining Share And Leadership in Emerging Markets
Figure 5-16
Philips Delivering Margin Improvement and Decreasing
Manufacturing Overhead
Figure 5-17
Philips Healthcare Information Systems Market Shares
Table 5-18
VRI Units Monitored
Table 5-19
VRI Services to Partners





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