ICU Medical Launches Cardioflo™ Minimally Invasive Hemodynamic Monitoring Sensor System

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January 17, 2013 ICU Medical Launches CardioFlo™ Minimally Invasive Hemodynamic Monitoring Sensor System Shown in clinical testing to provide accurate, reliable, and cost-effective hemodynamic monitoring, CardioFlo will be introduced at the Society of Critical Care Medicine (SCCM) Critical Care Congress in San Juan, Puerto Rico SAN CLEMENTE, Calif., Jan.17, 2013 – ICU Medical, Inc. (Nasdaq:ICUI) today announced it will launch the CardioFlo hemodynamic monitoring sensor system at the Society of Critical Care Medicine (SCCM) Critical Care Congress in San Juan, Puerto Rico, January 19-23, 2013. CardioFlo is a minimally invasive hemodynamic monitoring sensor system that, when used with an existing arterial catheter and connected to an Edwards Lifesciences Vigileo® monitor, provides accurate and reliable hemodynamic monitoring data and an average of 40% cost savings over the Edwards Lifesciences FloTrac® sensor. CardioFlo facilitates the real-time assessment of hemodynamic and cardiovascular status, helping guide clinical decision- making and effective management of critically ill patients. In clinical testing, the level of agreement between the hemodynamic data provided by the Edwards Lifesciences FloTrac and the ICU Medical CardioFlo sensor systems was within one percent. As a result, CardioFlo provides a cost-effective alternative to the FloTrac sensor without sacrificing accuracy or reliability. ICU Medical’s proven hemodynamic monitoring technology has been providing clinicians with accurate and reliable measurements for more than 30 years. As part of ICU Medical’s Critical Care product line, CardioFlo is available with the SafeSet™ closed blood sampling system, which allows clinicians to reduce blood discard waste during diagnostic phlebotomy by reinfusing it to the patient. The launch of CardioFlo reflects ICU Medical’s commitment helping clinicians increase clinical and economic efficiencies by delivering accuracy and reliability while decreasing costs. Contact: Tom McCall Vice President, Marketing 949-366-4368 [email protected] About ICU Medical, Inc.: ICU Medical, Inc. develops, manufactures and sells innovative medical devices used in vascular therapy, oncology and critical care applications. ICU Medical’s products improve patient outcomes by helping prevent bloodstream infections and protecting healthcare workers from exposure to infectious diseases or hazardous drugs. The company’s complete product line includes custom IV systems, closed delivery systems for hazardous drugs, needlefree IV connectors, catheters and cardiac monitoring systems. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical, Inc. can be found at www.icumed.com. *The FloTrac and Vigileo trademarks are owned by Edwards Lifesciences and not ICU Medical. ICU Medical does not manufacture or sell either the FloTrac Sensor or Vigileo Monitor..

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Medical Policy
bmchp.org | 888-566-0008 wellsense.org | 877-957-1300 Medical Policy Ambulatory Cardiac Monitors (Excluding Holter Monitors) Policy Number: OCA 3.35 Version Number: 24 Version Effective Date: 03/01/21 + Product Applicability All Plan Products Well Sense Health Plan Boston Medical Center HealthNet Plan Well Sense Health Plan MassHealth Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options ◊ Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options. Policy Summary The Plan considers the use of ambulatory cardiac monitors in the outpatient setting to be medically necessary if the type of ambulatory cardiac monitor is covered for the Plan member and ALL applicable Plan criteria are met, as specified in the Medial Policy Statement and Limitations sections of this policy. Plan prior authorization is required. When the device is covered for the member, medically necessary ambulatory cardiac monitors utilized in the outpatient setting may include ambulatory cardiac event monitors, mobile cardiac outpatient telemetry, and/or single-use external ambulatory electrocardiographic monitoring patches available by prescription. Ambulatory Cardiac Monitors (Excluding Holter Monitors) + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members.
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Clinical Research Protocol
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Appropriate Usage of Continuous Cardiac Monitoring in the Inpatient Setting: a Literature Review
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Cardiac Monitoring Infographic
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MEDICAL COVERAGE POLICY SERVICE: Cardiac Monitoring
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Regional ST-Segment Monitoring Self
ST-Segment Monitoring Self-Learning Package 1 Page This self-learning package is intended to be supplementary information and is not intended to replace Policy and Procedures, Guidelines and/or critical thinking. Developed by: SBH Cardiac Sciences/Critical Care Clinical Educators Reviewed and Revised by: The Regional Critical Care Policy and Procedure 2 Committee Page This self-learning package is intended to be supplementary information and is not intended to replace Policy and Procedures, Guidelines and/or critical thinking. Table of Contents: Purpose, Objectives and Instructions 4 Normal Cardiac Cycle Review 5 Clinical Conditions for ST-Segment Monitoring 6 Lead Placement 6 Ensuring ST-Segment Accuracy 7 Considerations with ST-Segment Monitoring 7 What to do if ST-Segment Changes are Noted 8 What to Document and Where 8 In Summary 9 Reference 9 Appendix A: Philips Monitor Setup 11 Appendix B: Spacelabs Monitor Setup 13 Appendix C: Documentation Examples 15 Validation Exercise (site/program specific) See Educator 3 Page This self-learning package is intended to be supplementary information and is not intended to replace Policy and Procedures, Guidelines and/or critical thinking. PURPOSE The purpose of this package is to provide the nurse working in cardiac monitored areas education to care for patients requiring ST-segment monitoring. OBJECTIVES After completing this package, the learner will be able to: 1. Explain the importance of ST-segment monitoring for different patient populations. 2. Identify appropriate ECG lead placement based on patient population. 3. Identify the appropriate assessment, interpretation, treatment, and documentation for ST-segment monitoring. INSTRUCTIONS This package is designed to be a supplementary review to any previously acquired knowledge and experience regarding ST-segment monitoring.
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Cardiac Monitoring and Qtc Assessment Guidelines
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Cardiac Monitoring Devices in the Outpatient Setting
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Telemetry– Related Events
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