Lisle, Illinois, USA. 23 May 2022. Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced positive data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella™ Pulmonary Artery Pressure Sensor System (Cordella Sensor) in New York Heart Association (NYHA) class III heart failure patients.
The prospective, multi-center trial met all primary safety and efficacy endpoints and resulted in low rates of HF hospitalization, further validating pulmonary artery (PA) pressure-guided HF management as standard of care for NYHA class III heart failure patients. Data from the SIRONA 2 trial was presented in a late-breaking session at European Society of Cardiology’s (ESC) Heart Failure Association (HFA) 2022 annual conference in Madrid, Spain on May 22nd.
“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,” stated Cardiologist Prof. Dr. Wilfried Mullens at Hospital Oost-Limburg in Genk and University Hasselt, Belgium. “The daily measurements provided a comprehensive clinical picture of the patient’s health over time which supported guideline directed medical therapy (GDMT) resulting in excellent clinical outcomes with low heart failure hospitalization (HFH) rates.”
The open-label, single-arm SIRONA 2 trial included 70 patients who were successfully implanted with the Cordella Sensor at seven European sites across Ireland, Belgium and Germany. The results confirmed a strong safety profile with no PA sensor failures, only one device / system related complication (DSRC = 1.3%) and 0% mortality at 90 days. The primary efficacy endpoint of accuracy, comparing Cordella Sensor with the gold standard fluid-filled reference catheter accuracy at 90 days, was also met.
In addition, the study demonstrated a low 6-month HF hospitalization event rate (0.16) with the majority of patients improving their NYHA classification (67.5%). Compliance with daily readings of PA pressure, weight, blood pressure, heart rate and blood oxygen were consistently above 93% over 6 months. Moreover, patients overwhelmingly found the system easy to use (94%) and were knowledgeable about their normal range of daily measurements (67%).
Key SIRONA 2 findings
• Excellent safety outcome without any PA sensor failures and 0% mortality at 90 days
• Equivalent accuracy of PA pressure measurement with gold standard fluid-filled reference catheter (Swan-Ganz) using two one-sided t-test (TOST) (p=0.003)
• Low heart failure hospitalization event rates per patient at 3 and 6 months (0.11 and 0.16, respectively)
• 65.7% of patients had improved NYHA classification at 90 days
• Consistent high patient compliance with daily patient measurements – 93% compliance at 180 days
• 84% of patients preferred PA pressure reading in the seated position instead of lying flat
“The presentation of the SIRONA 2 data is an exciting milestone for Endotronix and builds on the findings from our first-in-human trial to further validate the safety and efficacy of the Cordella Sensor,” said Katrin Leadley, MD, Chief Medical Officer of Endotronix. “We are encouraged by the meaningful improvement in patient outcomes the study demonstrated. This expands our clinical experience to a larger population and is a positive precursor for PROACTIVE-HF, our pivotal trial, which is expected to complete enrollment later this year.”
PROACTIVE-HF is the first global IDE study for PA pressure-guided heart failure management and is currently enrolling patients to further validate the clinical findings from SIRONA 2.
Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. Their solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data system and at home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure. Learn more at www.endotronix.com.
The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S. The Cordella PA Sensor is currently under clinical investigation and is not currently available for commercial use in any geography.
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For further information, please contact Vicky La Touche-Price at Seroba Life Sciences on +35316334028.