Endotronix Submits PMA Application for Cordella PA Sensor System

January 5, 2024—Endotronix, Inc. announced the submission of a premarket approval (PMA) application to the FDA for its Cordella pulmonary artery (PA) sensor system.

According to Endotronix, Cordella is a heart failure (HF) patient management platform that delivers proactive PA pressure data and noninvasive vital health data for comprehensive HF management at home. Its devices are intended to securely transmit daily health information to the managing clinician for supporting optimal dosing of guideline-directed medical therapy to reduce congestion and engaging patients with trended health data.

In April 2023, the company announced completion of enrollment in the PROACTIVE-HF pivotal trial. The company noted that it expects to share primary endpoint results from the trial in the first half of 2024.

The 450-patient PROACTIVE-HF study is being conducted through an FDA investigational device exemption (IDE). It is evaluating the safety and efficacy of the Cordella PA sensor in the treatment of patients with HF. Enrollment in the study commenced in February 2020.

In October 2023, the company announced it received FDA approval for an IDE for the PROACTIVE-HF 2 multicenter study, which will evaluate the Cordella system in the treatment of patients with HF.