FDA Grants Premarket Approval to Endotronix’s Cordella Pulmonary Artery Sensor System to Support Patients with Heart Failure

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The FDA has granted Premarket Approval (PMA) to Endotronix’s Cordella Pulmonary Artery (PA) Sensor System for use in patients with New York Heart Failure (NYHA) class III heart failure. According to the company, the approval marks the first PA pressure-guided platform for home-based comprehensive heart failure management. Additionally, the device operates by providing daily PA pressure readings from an implanted sensor along with non-invasive vitals such as blood pressure, heart rate, and weight.¹

"This approval is very exciting and has the potential to transform care for HF patients. Endotronix's solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits," national trial principal investigator Liviu Klein, MD, MS, section chief, advanced heart failure, mechanical circulatory support, pulmonary hypertension, and heart transplant, University of California San Francisco, said in a press release. "PROACTIVE-HF demonstrated 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."

Approval of the sensor system was based on data from the multi-center, prospective PROACTIVE-HF trial, which implanted 528 NYHA class III HF patients across 75 sites in the United States and Europe. The trial met its primary safety and efficacy endpoints as well as multiple secondary endpoints.^1,2

Results found that after implantation, a significantly low rate of hospitalization at 0.159 due to heart failure and all-cause mortality at the six-month mark. Further, results found a 23-meter improvement in a six-minute walk test, improvement in NYHA designation for 144 patients, an average decrease of 2.2 lbs in at-home weight, a 5.9 mmHg decrease for in-office systolic blood pressure from baseline, and a 2.4 mmHg decrease in seated mean PA pressure from baseline for congested patients.²

"These results are the culmination of many years of hard work and dedication by the Endotronix team and our clinical partners as we strive to provide best-in-class care for heart failure patients," said Harry Rowland, CEO, co-founder of Endotronix, in a press release. "We believe proactive, comprehensive care with Cordella improves the lives of patients living with heart failure and PROACTIVE-HF provides compelling evidence to support this new approach to impactful remote care delivery. With commercial launch expected later this year, we look forward to supporting clinicians in helping heart failure patients lead more full and active lives."

According to Endotronix, Cordella also permits seated PA pressure measurements with a handheld reader, patient visibility into key health trends to support healthy lifestyle changes, secure tablet messaging between clinical teams, patients, and caregivers, and implantation reimbursement.

Cordella is expected to launch in the United States later this year, while also submitting for CE Mark review in Europe. A decision on European market access is expected next year.¹

"At Endotronix, we firmly believe that innovation can drive patient care excellence in the home and ultimately change outcomes for patients with heart failure, one of the largest cost categories in healthcare. The FDA's approval validates this foundational belief and is a major milestone for our company and the field of HF management," said Rowland, in the press release. "With this approval, we will deliver proactive, comprehensive care that extends optimal HF therapeutic management to more patients, keeping them out of the hospital and living more fulfilling lives."

References

1. Endotronix Receives FDA Premarket Approval of the Cordella™ PA Sensor System for the Treatment of Heart Failure. PR Newswire. June 24, 2024. Accessed June 25, 2024. https://www.prnewswire.com/news-releases/endotronix-receives-fda-premarket-approval-of-the-cordella-pa-sensor-system-for-the-treatment-of-heart-failure-302179602.html

2. Endotronix Presents Positive PROACTIVE-HF Clinical Trial Results for its Cordella Pulmonary Artery Sensor. PR Newswire. March 5, 2024. Accessed June 25, 2024. https://www.prnewswire.com/news-releases/endotronix-presents-positive-proactive-hf-clinical-trial-results-for-its-cordella-pulmonary-artery-sensor-302080673.html