Clarity in Heart Failure Patient Care | Abbott
CARDIOVASCULAR
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Clarity in Care

CardioMEMS™ HF System Now Approved to Help More Patients

The CardioMEMS HF System has been proven to reduce heart failure hospitalizations,1 which can help slow the progression of heart failure in New York Heart Association (NYHA) Class II and III patients, regardless of ejection fraction.

Now you can help slow the progression of heart failure, since the new indication allows us to bring the benefits of the CardioMEMS HF System to healthier NYHA Class II and III patients who have had an elevated BNP, with or without a recent heart failure hospitalization. That means you don't have to wait for a patient to have a heart failure hospitalization before being able to customize their treatment plan and prevent further decompensation.

PRESYMPTOMATIC DATA

Monitoring pulmonary artery (PA) pressure daily, the CardioMEMS HF System gives you unique presymptomatic data that you do not get from any other remote hemodynamic monitor. This important data is an early indicator of worsening heart failure and can inform proactive treatment adjustments up to thirty days before weight gain, or other heart failure symptoms appear.3

Pathophysiology of Congestion and Decomposition

Preventing Heart failure hospitalizations

After a heart-failure hospitalization, one in four patients are back in the hospital within 30 days.2 The CardioMEMS HF System is clinically proven to reduce heart-failure hospital readmission by 78%.3

78% Reduced Readmissions

With 93% compliance demonstrated in real-world, post-approval studies,4 the CardioMEMS HF System engages heart failure patients more actively in their health and treatments.

93% Compliance

In clinical studies, heart failure patients with the CardioMEMS HF System had 57% fewer hospitalizations than patients without.5

57% Less Hospitalizations

Preserves Patient Lifestyles

Manage Patients Remotely

Remote management means a decrease in frequency of visits and commuting to appointments, so patients enjoy more of their day-to-day activities.

Improve Quality of Life

Presymptomatic data allows you to provide personalized, trend-based heart failure management. This proactive care can make patients feel re-energized and may help prevent them from being readmitted to the hospital.
 

25,000+ Patients Implanted

Now that it’s approved for more patients, the CardioMEMS HF System should be considered for all your heart failure patients, who are actively being treated to prevent heart failure progression and hospitalizations. With the CardioMEMS HF System, you’ll have access to your patient’s data in real time so they can worry less about their heart failure and get back to focusing on life.

References

  1. Lindenfeld J, Zile MR, Desai AS, et al. Hemodynamic-guided management of heart failure (GUIDE-HF): a randomized controlled trial. Lancet 2021;398:991-1001.
  2. Muhammad Shahzeb Khan, Jayakumar Sreenivasan, Norman Lateef, Marwan S. Abougergi, Stephen J. Greene, Tariq Ahmad, Stefan D. Anker, Gregg C. Fonnarow, Javed Butler. Trends in 30- and 90-Day Readmission Rates for Heart Failure. AHA Journals. 2021; https://doi.org/10.1161/CIRCHEARTFAILURE.121.008335
  3. Adamson, et al. Pulmonary artery pressure-guided heart failure management reduces 30-day readmissions. Circulation: Heart Failure. 2016;115.002600.
  4. Heywood JT, Jermyn R, Shavelle D, et al. Impact of practice-based management of PA pressures in 2000 patients implanted with the CardioMEMS sensor. Circulation. 2017;135:1509-17.
  5. Shavelle D., et al. Lower rates of heart failure and all-cause hospitalizations during pulmonary artery pressure-guided therapy for ambulatory heart failure. Circulation: Heart Failure. Advance online publication. https://doi.org/10.1161/CIRCHEARTFAILURE.119.006863

INDICATIONS, SAFETY AND WARNINGS

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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.

CardioMEMS™ HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.

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

CardioMEMS™ HF System Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: air embolism, allergic reaction, infection, delayed wound healing, arrhythmias, bleeding, hemoptysis, hematoma, nausea, cerebrovascular accident, thrombus, cardiovascular injury, myocardial infarction, death, embolization, thermal burn, cardiac perforation, pneumothorax, thoracic duct injury and hemothorax.

myCardioMEMS™ Mobile App Limitations: Patients must use their own Apple or Android mobile device to receive and transmit information to the myCardioMEMS™ Mobile App. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi) available. The myCardioMEMS™ Mobile App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgement that the PA pressure readings have been received. However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.

MAT-2200872 v1.0

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