FDA-Approved App Enables Pulmonary Pressure Monitoring and Medication Guidance in Heart Failure

Rising pulmonary artery pressure can precede decompensation by weeks, underscoring the need for timely monitoring and treatment adjustments between visits. Clinicians increasingly seek ways to keep patients engaged in daily management of their condition. New FDA-approved capabilities now allow patients to view pulmonary artery pressure trends and receive personalized medication updates through a smartphone app.

Abbott has received U.S. Food and Drug Administration (FDA) approval for updates to the CardioMEMS HF System that enable new patient-facing features through the CardioGuide HF App, including direct access to pulmonary artery pressure (PAP) readings on smartphones. The CardioMEMS HF System has been used for more than a decade to support clinician decision-making by tracking PAP, which can rise weeks before symptoms of worsening heart failure appear. The newly approved capabilities are intended to keep patients informed and connected to their care teams between office visits.

The CardioMEMS HF System measures PAP through a permanently implanted sensor in the pulmonary artery. Patients obtain readings using the CardioMEMS HERO device, which transmits data to care teams through the Merlin.net Patient Care Network Portal. The CardioGuide HF App complements this workflow by displaying an individual’s PAP values and trends on iOS or Android devices, giving patients direct visibility into their hemodynamic status.

A new Dynamic Treatment Plan (DTP) feature allows clinicians to create personalized medication adjustment plans driven by changes in PAP. When enabled, DTP can send medication adjustment instructions directly to patients through the CardioGuide HF App, providing timely guidance between clinic visits. The CardioMEMS HF System has been shown to reduce heart failure hospitalizations and mortality risk, and the company plans to make the CardioGuide HF App and DTP available later this year.

“Heart failure can worsen before patients notice shortness of breath, swelling or weight gain. Pulmonary artery pressure readings can help identify changes earlier, giving care teams an opportunity to adjust treatment before symptoms develop. By giving patients access to their pressure trends and personalized guidance from their care team, the CardioGuide HF App can help patients better understand their condition, understand why treatment adjustments are recommended, and take a more active role in managing their heart failure,” said Andrew J. Sauer, M.D., cardiologist and vice president for research at Saint Luke's Mid America Heart Institute and professor of medicine at the University of Missouri-Kansas City.