The U.S. Food and Drug Administration (FDA) on June 24 gave premarket approval for Endotronix, Inc.’s Cordella™ Pulmonary Artery Sensor System for the treatment of patients with NYHA class III heart failure (HF).

The approval comes after agency review of results from the PROACTIVE-HF Pivotal Trial, which found that “with Cordella clinicians achieved more optimal and timely dosing of key HF medications, significantly improving outcomes. In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes.”

The HF management platform will launch in the U.S. this year. To learn more about Cordella and its recent approval, access the company press release.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Pulmonary Artery, Heart Failure, United States Food and Drug Administration, ACC Advocacy