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CARDIOVASCULAR
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Even in the new normal — or the new abnormal — of the COVID-19 pandemic, time marches on.

It’s easy for anyone, from doctors providing care to those needing it, to get anxious missing their old reality and familiar routines.

That natural urge to get from “abnormal” back to something like “normal” is bigger than two small letters. But that journey from points “a” and “b” isn’t always a straight line.

It takes innovative thinking to see possibilities that weren’t there before.

Hospitals, health systems and physicians are searching for new ways to ensure care while minimizing risk to the vulnerable. In many corners, what was “elective” has become critical. And while clinical trials need enrollment, research activities were temporarily deprioritized.

As healthcare providers resume operations unrelated to novel coronavirus and return to treating those who have put off care and elective procedures, they need partners with broad portfolios they can rely on. They need support that can be delivered even as the world continues to proactively keep its social distance.

What they need is a partner such as Abbott.

Here’s how we’re helping throughout the healthcare system, from testing to helping those being tested by the circumstance.

Distance Making Hearts Flow Stronger

Telehealth and remote monitoring can turn living rooms into virtual exam rooms for healthcare providers and people sheltering in place while living with chronic diseases and cardiovascular conditions that require regular medical attention. And during the COVID-19 pandemic, the Centers for Medicare and Medicaid Services (CMS) has expanded the use of telehealth for the people it covers.

That’s helpful for doctors treating people living with potential arrythmias.

Confirm Rx ICM is an insertable cardiac monitor designed not only to detect difficult to diagnose arrhythmias but also uses a smartphone app to send real-time information to doctors anywhere in the world to see how their hearts are performing without the need to visit their doctor.

Care teams managing heart failure patients have traditionally had to rely on markers such as weight, blood pressure and symptoms, leaving little time to react before hospitalization.

With the CardioMEMS HF System, remote monitoring of changes in pulmonary artery (PA) pressure can serve as an early indicator of worsening heart failure. This proactive approach puts actionable data in clinicians’ hands for more informed decision-making, all while keeping people at home — and out of the hospital.

And as the country has ramped up production of ventilators in response to the COVID-19 pandemic, our CentriMag System is able to treat people who are critically ill fighting coronavirus based on the U.S. Food and Drug Administration (FDA) enforcement policy during the COVID-19 pandemic.

CentriMag temporarily replaces the function of the heart and lungs, giving the body time to heal. As COVID-19 attacks the body, CentriMag gives hospitals another option to give critically ill patients a better chance at recovery.

Socially Distant, Professionally Connected

Through the months of sheltering in place, our commercial and clinical teams have remained active, finding new ways to communicate and educate healthcare providers.

An example: Many physicians have spent some time catching up on the latest data, research and clinical thinking, with Abbott’s latest information at their fingertips. And in response, we have ensured our latest data and research are available on the Web, as doctors prepare to resume broader patient care.

Another example: With the cancellation of key 2020 congresses such as the European Heart Rhythm Society (ERHA) and the Heart Rhythm Society (HRS) in the wake of COVID-19, providing access to the latest clinical information is even more important. We have built virtual congress platforms to share clinical presentations as well as highlight newly released data. Visit our virtual HRS portal here.

Here’s another: Our cardiac rhythm management and electrophysiology teams have partnered with HRS on a symposium covering the impacts of COVID 19 on implant procedures and long-term patient care management.

We also linked to educational resources geared toward addressing critical, day-to-day needs of healthcare providers so they can continue to support their clinics and patients.

We have also increased tenfold our webinars with industry experts to provide better understanding of health policy and emergency changes to federal law to how treatments for arrythmia, heart failure and coronary syndrome have been impacted by COVID-19. Hundreds have attended. These virtual meeting grounds have been critical to physicians sharing information among providers.

We’re connecting these dots by connecting healthcare professionals online, through our primary cardiovascular health site. And there’s more from Abbott at HRS’s site.

Tested: Tried And True

Our diagnostics tests for novel coronavirus have now received six emergency use authorizations from the U.S. FDA.

It’s simple math: More testing capacity and capability mean more people are able to receive the care they need and get much-desired information about their health.

For doctors and medical professionals treating patients every day on the front lines, we understand our responsibility to deliver an uninterrupted supply of products that are where they need to be, when they need to be there. That service and consistent flow of products is crucial to delivering the best care.­­

Like it is for you, this is all just … normal for Abbott.

Even in abnormal times, seeing innovative possibilities is … normal.

Even when something “novel” demands necessary innovation, that’s … normal.

So as this COVID-19 pandemic requires solutions that aren’t always as simple as a straight line from A to B, we’re that partner with the portfolio, technological solutions and training to rely on.

And like you, to us there’s not one thing abnormal about any of it.

The Abbott SARS-CoV-2 tests run on the Abbott m2000 RealTime System, ID NOW, Alinity i, ARCHITECT and Alinity m platforms have not been FDA cleared or approved. These tests have been authorized by U.S. FDA under EUAs for use by authorized laboratories and have been authorized only for the detection of nucleic acid from SARS-CoV-2 or detection of IgG antibodies against SARS-CoV-2, and not for any other viruses or pathogens. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Indications, Safety & Warnings

Confirm Rx™

Model DM3500
Insertable Cardiac Monitor

Indications: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx™ ICM has not been specifically tested for pediatric use.

Contraindications: There are no known contraindications for the insertion of the Confirm Rx™ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Additional information: Clinicians must log onto Merlin.net™ Patient Care Network to view transmissions from patients’ Confirm Rx™ ICM. On Merlin.net™ PCN they can configure transmission schedules and enable or disable features on a patient’s myMerlin™ mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.

Limitations: Patients may use their own Apple‡ or Android‡ mobile device to transmit information from their Confirm Rx™ ICM using the myMerlin™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology enabled and data coverage (cellular or WiFi‡) available. The myMerlin™ mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was not sent successfully. However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes, or data processing.

An Abbott mobile transmitter is available for patients without their own compatible mobile device.

CardioMEMS™

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications and Usage: The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: Infection, Arrhythmias, Bleeding, Hematoma, Thrombus, Myocardial infarction, Transient ischemic attack, Stroke, Death, and Device embolization.

CentriMag™

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

CentriMag Circulatory Support System Indications [PMA Approval; 30-day use]: Temporary circulatory support for up to 30 days for one or both sides of the heart to treat post-cardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.

CentriMag Circulatory Support System Contraindications [PMA Approval; 30-day use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.

Humanitarian Device Statement: The CentriMag Circulatory Support System is authorized by Federal Law for temporary circulatory support for up to 30 days for patients in cardiogenic shock due to right ventricular failure. The effectiveness of this device for this use has not been demonstrated.

CentriMag RVAS Indications [Humanitarian Exemption Device (HDE) Approval; 30-day use]: The CentriMag Circulatory Support System is intended to provide temporary circulatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure.

CentriMag RVAS Contraindications [Humanitarian Exemption Device (HDE) Approval; 30-day use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.

CentriMag Blood Pump Indications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.).

CentriMag Blood Pump Contraindications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.

PediMag™ Blood Pump Indications for Use [510(k) Clearance; 6-hour use]: The PediMag Blood Pump is indicated for use with the CentriMag Circulatory Support System console and motor to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.).

PediMag Blood Pump Contraindications [510(k) Clearance; 6-hour use]: The PediMag Blood Pump is contraindicated for use as a cardiotomy suction device. The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.

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