CardioMEMS Set for Broader Use

FDA approves expanded indication, boosting access to Abbott's connected tech for earlier-stage heart failure.

Strategy and Strength|Feb.22, 2022

Thirty years ago, heart failure was a death sentence.

Today, it's not. 

Helping drive this transition has been CardioMEMS HF System, Abbott’s leading remote monitoring technology that tracks blood pressures in the lung circulation (pulmonary artery) and wirelessly transmits from virtually anywhere, to the patient's clinical team. Data from this paperclip-sized device allow doctors to intervene, if necessary, before heart failure worsens.

And now, the U.S. Food and Drug Administration (FDA) has approved expanding the indication for CardioMEMS beyond people with more advanced (Class III) heart failure to those in earlier stages of the condition (Class II), and for patients who undergo a blood test showing elevated levels of certain biomarkers that indicate worsening heart failure.

Here's What This Means

Significantly more Americans are now eligible to receive the remote heart-failure sensor, enabling broader access to the life-changing technology.

How many more?

With the approval, an additional 1.2 million people in the U.S.1 are now eligible for this technology.

The expanded indication was supported by data from the large GUIDE-HF trial, which found that people with earlier-stage heart failure (Class II) have better outcomes with fewer hospitalizations when their therapy is guided by remote pulmonary pressure monitoring.

"Heart failure is a race against time where too often we’re behind because patients are not getting care early enough," said Philip B. Adamson, M.D., chief medical officer of Abbott's Heart Failure business. "This approval means physicians can treat more people with earlier-stage heart failure, providing the opportunity to prevent further suffering and possibly avoid later-stage progression that can have a profound impact on a person’s quality of life." 

CardioMEMS set for broader use

CardioMEMS' Growing Market

With the FDA's decision, the number of people who could benefit from the technology could grow as people continue living longer, possibly creating great need for innovative heart treatments.

By 2050, 1 in 6 people in the world will be over age 65 (16%), up from 1 in 11 (9%) in 2019, according to United Nations' data.2 And heart failure is the leading cause of hospitalizations among people age 65 and older.

Abbott's 2021 heart failure business sales of nearly $900 million (19.1% organic growth compared to 2020), coupled with the world's aging population, highlight the company’s strength in the market as well as its potential to expand.

Expected to help sustain this momentum is CardioMEMS, a first-of-its-kind approach to redefining heart failure management that Abbott scientists say is in the early innings of its evolution.

"We're just now opening the door to understanding heart failure. We're reducing hospitalizations. That's what we've accomplished thus far," Dr. Adamson said. "The next step is even going to be brighter. I'm really excited about how this is going to transition into the next iteration of how we care for people with heart failure."

Learn more about Abbott's CardioMEMS and its other game-changing heart tech.


1Abbott Heart Failure Navigant Data 2021.
2 United Nations' 2019 Revision of World Population Prospects.



By Prescription Only

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.

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™ App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgment 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.