Endotronix Cordella Pulmonary Artery Sensor Studied in 12-Month SIRONA 2 Data

May 22, 2023—Endotronix, Inc. announced 12-month data from the SIRONA 2 clinical trial demonstrating that long-term use of the company’s Cordella pulmonary artery (PA) sensor was associated with significant improvements in patient quality-of-life metrics and low heart failure (HF) hospitalization and death (HFH/D) event rates for New York Heart Failure (NYHA) class III patients.

The company noted that the results expand on the positive 90-day primary endpoint data on device safety and pressure accuracy for the Cordella PA sensor published in June 2022 by Faisal Sharif, MBBS, PhD, et al in ESC Heart Failure (2022;9:2862-2872).

The 12-month results were presented by Professor Birgit Aßmus, MD, at Heart Failure 2023, the European Society of Cardiology’s annual conference held May 20-23 in Prague, Czechia.

Prof. Aßmus, who is an HF cardiologist at the University of Giessen in Giessen, Germany, commented in the Endotronix press release, “Adding to a robust foundation of clinical evidence supporting the use of Cordella, the 12-month SIRONA 2 data further validate the benefit of PA pressure–guided therapy to improve patient outcomes for NYHA class III patients.”

Prof. Aßmus continued, “Cordella’s comprehensive approach consists of PA pressure data plus noninvasive data, including blood pressure, weight, and heart rate, which enables my team to efficiently titrate key HF medications remotely and help patients feel better. By actively monitoring the trended health data, we can bring down the PA pressures to avoid acute HF hospitalizations, which delivers meaningful benefits to our overall health system and to patient lives.”

According to the company, the Cordella patient management platform provides both critical PA pressure data with an implanted sensor and noninvasive vitals for comprehensive clinical management delivered in the patient’s home. The easy-to-use devices securely transmit a patient’s daily health status for trended insights that support optimal dosing of guideline-directed medical therapy across all types of HF.

Additionally, the company noted that the system allows patients to view their trended health data, which has been shown in clinical evaluation to support healthy lifestyle choices. The streamlined workflow enhances current clinical practice, providing a scalable solution that enables new treatment standards to reduce and prevent HF congestion.

Endotronix stated that SIRONA 2 is an open-label, single-arm trial of 70 European patients that met its primary endpoints for safety and accuracy with the previously reported 90-day results. The 12-month results extended both the strong safety profile, with no PA sensor failures and no additional device/system-related complications (1.3%), as well as accurate PA pressure measurement, with good agreement with the gold-standard fluid-filled reference catheter (Swan Ganz). The recent results also met secondary endpoints for validated patient quality-of-life metrics and demonstrated low event rates for HFH/D as indicated below.

As outlined by the company, the 12-month SIRONA 2 trial’s key findings include the following:

• Significant improvement in patient quality-of-life metrics, including NYHA classification over 12 months (P < .0001) and 6-minute walk test distance at both 3 months (P = .005) and 12 months (P = .02)
• Low event rates for HFH/D with only five deaths (7.1%) at 12 months; cumulative hazard rate for HFH (0.27) and HFH/D (0.33)
• 78.6% reduction in HFH rate in the year following implant compared to the year prior
• Consistently high patient compliance with daily submissions of heath data of 95% at 12 months

Endotronix advised that the Cordella Sensor is under clinical investigation and is not available for commercial use in any markets. The Cordella HF system, without the sensor, is available for commercial use in the United States and European Union.