Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, has announced the 100th global implant of the Cordella Pulmonary Artery Pressure Sensor (Cordella Sensor) by Cardiologist and top worldwide implanter Faisal Sharif, MD of Bon Secours Hospital and Director of Cardiovascular Research at NUIG, both in Galway, Ireland. The sensor provides key heart pressure readings as part of the Cordella™ Heart Failure System (Cordella System) to empower clinicians to proactively adjust therapy and medications remotely without the need for office visits. The milestone included patient enrollment across the company’s three clinical trials: SIRONA, SIRONA II, and PROACTIVE-HF. The SIRONA II and PROACTIVE-HF trials, which are currently enrolling, will support regulatory submission for CE Mark and Pre-Market Approval (PMA) of the pulmonary artery (PA) sensor and lead the company towards global commercialization.
“PA pressure-guided heart failure management is fast becoming the standard of care in NYHA Class III patients,” stated Dr. Liviu Klein, Director of the Mechanical Circulatory Support Program at UCSF and National Principal Investigator of the PROACTIVE-HF trial. “As clinicians look to better manage heart failure, our goal is to improve quality of life for patients while keeping them out of the hospital, which is particularly important in today’s times. With the comprehensive clinical data provided by the Cordella System with the PA Sensor, my team can remotely titrate medications to deliver guideline directed therapy and ultimately, improve patient outcomes.”
The Cordella System enables scalable remote heart failure management and aims to increase guideline directed medical therapy (GDMT) adherence and provide early detection of worsening heart failure. The platform consists of a comprehensive patient management system that securely collects non-invasive daily health data, coupled with a seamlessly integrated, next-generation implantable PA pressure sensor. Together, they deliver the necessary information for clinicians to proactively titrate medications and improve patient care between office visits while supporting reimbursement for care delivery activities.
“Our clinical partners are amazing. We appreciate their tremendous effort in achieving this significant milestone and for their tireless dedication to improving patient care,” added Harry Rowland, co-founder and Chief Executive Officer of Endotronix. “Our team continues to focus on supporting our clinical sites and accelerating trial enrollment as we look to build momentum in preparation for a successful global commercialization of the Cordella Sensor.”
Endotronix Clinical Program
Endotronix is sponsoring a robust clinical program based on three foundational clinical trials: SIRONA (First-in-Human), SIRONA II (for CE Mark submission), and PROACTIVE-HF (for PMA submission). The SIRONA First-in-Human (FIH) trial, which is currently in the follow-up phase, was designed to prove the safety and accuracy of the Cordella Sensor. The study met primary accuracy and safety endpoints and demonstrated high patient compliance with daily measurements. Results from SIRONA FIH were published in the European Journal of Heart Failure (Oct 2020).1
Enrollment is ongoing for the SIRONA II and PROACTIVE-HF trials, which aim to provide regulatory approval of the Cordella Sensor in the E.U. and the U.S., respectively. Focusing on New York Heart Association (NYHA) Class III Heart Failure patients, both trials seek to demonstrate the benefits of comprehensive PA pressure-guided heart failure management.