Sam Brusco, Associate Editor05.23.22
Heart failure treatment company Endotronix shared data from the SIRONA 2 trial that evaluated its Cordella pulmonary artery pressure sensor system for New York Heart Association (NYHA) class III heart failure.
The trial met all primary safety and efficacy endpoints, with low rates of HF hospitalization. The data was presented at the European Society of Cardiology’s Heart Failure Association annual conference this week.
"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," Cardiologist Prof. Dr. Wilfried Mullens at Hospital Oost-Limburg in Genk and University Hasselt, Belgium told the press. "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."
To 70-patient trial saw 70 patients implanted with the Cordella sensor in sites across Ireland, Belgium, and Germany. Results showed a strong safety profile with no sensor failures and only one device/system related complication.
The Cordella sensor was compared to the gold-standard fluid-filled reference catheter at 90 days. Further, the HF hospitalization event rate (0.16) was very low, with 67.5% of patients improving their NYHA classification.
"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.
The trial met all primary safety and efficacy endpoints, with low rates of HF hospitalization. The data was presented at the European Society of Cardiology’s Heart Failure Association annual conference this week.
"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," Cardiologist Prof. Dr. Wilfried Mullens at Hospital Oost-Limburg in Genk and University Hasselt, Belgium told the press. "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."
To 70-patient trial saw 70 patients implanted with the Cordella sensor in sites across Ireland, Belgium, and Germany. Results showed a strong safety profile with no sensor failures and only one device/system related complication.
The Cordella sensor was compared to the gold-standard fluid-filled reference catheter at 90 days. Further, the HF hospitalization event rate (0.16) was very low, with 67.5% of patients improving their NYHA classification.
"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.
