LISLE, Ill., Jan. 8, 2018 /PRNewswire/ — Endotronix, Inc., a medical technology company providing device and digital health solutions for heart failure management, today announced successful first-in-human implantation of the Cordella™ Pulmonary Artery (PA) Pressure Sensor and initiation of the SIRONA First-in-Human (FIH) clinical trial. Cardiologists Prof. Dr. Wilfried Mullens of Ziekenhuis Oost-Limburg and University Hasselt and Dr. Matthias Dupont of Ziekenhuis Oost-Limburg, both co-investigators of the SIRONA trial, performed the first implant at the Hospital Ziekenhuis Oost-Limburg in Genk, Belgium.
The SIRONA FIH trial is designed to evaluate the safety and performance of the Cordella PA Pressure Sensor in the treatment of advanced heart failure patients who remain unstable despite standard of care medical management. The wireless Cordella PA Pressure Sensor, the implantable component of the Cordella™ Heart Failure (HF) System, provides PA pressure data readings that clinicians interpret to guide therapy and provide proactive HF management. Clinical studies have shown that regular PA pressure monitoring can provide earlier detection than other modalities of worsening heart failure, decrease HF-related hospitalizations by 37%, and reduce mortality by 57% for patients with heart failure with a reduced ejection fraction (HFrEF)1,2.
“We were extremely pleased with the Cordella PA Pressure Sensor implantation procedure experience and initial wireless PA pressure measurements,” commented Prof. Dr. Mullens. “Recent clinical data points 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.”
The Cordella HF System is a comprehensive, disease management system that enables on-going therapeutic interventions to improve patient quality of life and decrease heart failure readmissions. The system collects and securely transmits biometric and relevant clinical data to the heart failure clinician, creating accurate snapshots of the patient’s heath status over time. The myCordella™ Patient Management Portal is designed to streamline patient management for the clinician and support the delivery of complex chronic disease management.
“Implanting our first patient in the SIRONA trial is a significant achievement that moves us closer to our goal of providing comprehensive, proactive heart failure management,” said Harry Rowland, Chief Executive Officer and co-Founder of Endotronix. “We look forward to furthering the field of heart failure management by combining best-in-class sensing technology with best-in-class disease management solutions.”
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 post sensor implantation. Accuracy of the Cordella PA Pressure Sensor readings as compared to a fluid-filled PA pressure measurement taken by right heart catheterization (RHC) at 90-days is the primary efficacy endpoint.
About Endotronix
Endotronix, Inc., a medical technology company, is developing an integrated platform to provide comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. The company’s 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 http://www.endotronix.com.
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1Abraham WT, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized control study. Lancet. 2011 Feb 19;377(9766):658-66
2 Abraham WT, Adamson PB, et al. (2015, March). Pulmonary artery pressure management in heart failure patients with reduced ejection fraction significantly reduces heart failure hospitalizations and mortality above and beyond background guideline-directed medical therapy. Abstract 902-04 presented at ACC 2015, San Diego, California.
SOURCE Endotronix, Inc.
