Endotronix Begins SIRONA FIH Trial of Cordella Pulmonary Artery Pressure Sensor
January 8, 2018—Endotronix, Inc., which develops device and digital health solutions for heart failure (HF) management, announced the successful first-in-human (FIH) implantation of its Cordella pulmonary artery (PA) pressure sensor and initiation of the SIRONA FIH clinical trial. The first implantation was performed by SIRONA trial investigators, Prof. Wilfried Mullens, MD, and Matthias Dupont, MD, who are cardiologists with Ziekenhuis Oost-Limburg in Genk, Belgium.
The wireless Cordella PA pressure sensor, which is the implantable component of the Cordella HF system, provides PA pressure data readings that clinicians interpret to guide therapy and provide proactive HF management. The Cordella HF system is a disease management system that enables ongoing therapeutic interventions. The system collects and securely transmits biometric and relevant clinical data to the HF clinician, creating accurate snapshots of the patient’s health status over time. The system combines with the myCordella patient management portal, which is designed to streamline patient management for the clinician and support the delivery of complex chronic disease management.
According to the company, the SIRONA FIH trial is designed to evaluate the safety and performance of the Cordella PA pressure sensor in the treatment of advanced HF patients who remain unstable despite standard-of-care medical management.
The SIRONA trial will enroll up to 10 patients at two European sites. The primary safety endpoint is freedom from adverse events related to use of the system through 30 days after sensor implantation. The primary efficacy endpoint is accuracy of the Cordella PA pressure sensor readings as compared to a fluid-filled PA pressure measurement taken by right heart catheterization at 90 days.
In the Endotronix announcement, Prof. Mullens commented, “We were extremely pleased with the Cordella PA pressure sensor implantation procedure experience and initial wireless PA pressure measurements. Recent clinical data point to the value of regular PA pressure monitoring as an early indication of worsening of a patient’s heart failure condition. And coupling the sensor with Endotronix’s patient management platform for heart failure has the potential to improve the way this patient population is managed.”