FDA Approves Cordella Remote PA Pressure Monitoring System for HF

The US Food and Drug Administration has granted premarket approval to the Cordella pulmonary artery (PA) sensor (Endotronix; Naperville, IL), for patients with NYHA class III heart failure (HF).

The approval was based on evidence from the PROACTIVE-HF trial, which showed substantial reductions in PA pressure as well as improved quality of life and functional capacity in 456 patients who were implanted with the system then monitored by it over 6 months.

The system combines internal-pressure readings from a sensor implanted in the right pulmonary artery with noninvasive vital sign information, including blood pressure, heart rate, weight, and oxygen saturations taken via a Bluetooth-enabled blood pressure cuff and scale. Upon placing the handheld device up to their chest for less than a minute, patients can view their own data on an app while the system also transmits key information to physicians and care teams.

Notably, the device allows for PA pressure measurements to be taken while the patient is either seated or supine.

“PROACTIVE-HF demonstrated that with Cordella clinicians achieved more optimal and timely dosing of key HF medications, significantly improving outcomes,” national principal investigator Liviu Klein, MD (University of California San Francisco), said in a press release. “In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes.”

Speaking with TCTMD, Klein said a big advantage of this system over the currently available CardioMEMS device (Abbott) and other in-hospital monitoring methods is that it provides “much more physiologic data” because patients are taking their measurements in the seated position. “With the supine pressures, we may be using information somewhat incorrectly and adjusting medication somewhat incorrectly compared to the sitting pressures,” he explained.

As a whole, the Cordella system “feels more like modern technology” not only in the way it collects the data, but also how it integrates into the electronic medical record, Klein added. “It's much smoother with this new system versus having a website where you have to go and retrieve the data.”

With more than a decade’s worth of data supporting the use of implantable monitors, he said he is excited to now have a second-generation system to improve HF care. “Not only monitoring these pressures from home but acting on those pressures can impact survival and impact hospitalizations and patient's quality of life,” Klein said. The addition of other vital-sign information can “even further improve these outcomes, and we've seen that in the PROACTIVE study where the rates of hospitalization and mortality were actually much, much lower than what one had expected.”

The manufacturer plans a US launch of Cordella later this year, and the device has been submitted for CE Mark review. Also, the ongoing PROACTIVE-HF-2 trial will test the Cordella system for efficacy and safety in a population of patients with NYHA class II and III HF.