Endotronix last week announced that it received FDA approval to begin its multi-center Proactive-HF trial of the Cordella Pulmonary Artery Pressure Sensor System.
The trial is designed to help the Cordella Sensor reach pre-market approval faster and will begin enrollment in the third quarter of 2019.
“We are excited to begin enrollment in this groundbreaking trial that will provide the highest level of clinical evidence to redefine the standard of care for patients suffering from chronic heart failure,” chief medical officer Katrin Leadley said in a press release. “The trial design and treatment guidelines aim to proactively lower patient PA pressures and enable physicians to maintain target pressures, which we believe will decrease patient mortality and lower the rate of HF-related hospitalizations.”
Proactive-HF is a prospective, multi-center, randomized, controlled trial that will evaluate the safety and efficacy of the sensor in more than 950 patients in 60 sites across the U.S. It will also assess the benefits of PA pressure-guided management using the sensor for New York Heart Association Class III heart failure patients, as well as the rate of mortality and HF hospitalization of use of IV diuretics at 12 months.
Endotronix’s Cordella Sensor is used with the Cordella Heart Failure System that shows the comprehensive health status of patients at home using a remote patient management platform to securely collect and share data with healthcare providers.
“This is a pivotal milestone for both the company and patients suffering from heart failure. Proactive-HF is designed to show a definitive benefit for PA pressure-guided management and provide the data required for reimbursement of the implantable Cordella Sensor across the U.S.,” CEO Harry Rowland said. “This study along with our recently initiated CE Mark trial, Sirona II, will build a solid clinical foundation for market adoption of the Cordella Sensor and Cordella System.”