Endotronix’s Cordella PA Sensor Meets 90-Day Safety and Efficacy Endpoints in SIRONA 2 Trial

May 23, 2022—Endotronix announced data from the SIRONA 2 trial showing their Cordella pulmonary artery (PA) sensor system met all primary safety and efficacy endpoints at 90 days. The results were shared at a late-breaking session at the European Society of Cardiology’s Heart Failure Association 2022 conference held May 21-24 in Madrid, Spain.

SIRONA 2 is a prospective, open-label, single-arm, multicenter trial that included 70 patients from seven European sites across Ireland, Belgium, and Germany who had the Cordella PA sensor successfully implanted. The trial evaluated the safety and efficacy of the Cordella PA sensor in New York Heart Association (NYHA) class III heart failure patients.

The company’s reported safety profile included that there was no PA sensor failure, one device/system–related complication (1.3%), and 0% mortality at 90 days. The primary efficacy endpoint of the accuracy of PA pressure measurement compared with the gold standard fluid-filled reference catheter at 90 days was also met using two one-sided t-test (P = .003).

“In addition to achieving the primary safety and accuracy endpoints, the SIRONA 2 trial demonstrated a consistently high level of patient compliance with daily readings of PA pressure and physiologic data with a strong preference for performing PA pressure measurements from a seated position,” commented Prof. Dr. Wilfried Mullens in the company’s press release.

According to the company, patients’ compliance rate with daily readings of PA pressure, weight, blood pressure, heart rate, and blood oxygen were consistently above 93% over 6 months. Additionally, 84% of enrolled patients preferred a PA pressure reading in a seated position instead of lying flat.

“The daily measurements provided a comprehensive clinical picture of the patient’s health over time, which supported guideline-directed medical therapy resulting in excellent clinical outcomes with low heart failure hospitalization rates.” Prof. Dr. Mullens is a cardiologis at Hospital Oost-Limburg in Genk and University Hasselt, Belgium.

Endotronix reported the study showed a low 3- and 6-month heart failure hospitalization event rate per patient (0.11 and 0.16, respectively). Most patients (67.5%) had improved NYHA classification at 90 days.

Endotronix described the Cordella PA sensor as a next-generation wireless sensor that works with Cordella heart failure system sending daily health information about a patient to clinicians to enable them to proactively adjust therapy and medications remotely without the need for office visits.

According to the company, the Cordella system without the PA sensor, is available for commercial use in the United States and European Union. The Cordella PA sensor is under clinical investigation and not currently available for commercial use in any geography.