Endotronix took a big step toward its vision for pulmonary artery pressure-based heart failure medication optimization, releasing positive results from its Cordella Sensor’s PROACTIVE-HF pivotal trial.
The Cordella Solution sits at the intersection of medtech and digital health, combining an implanted PA sensor to measure congestion, a handheld PA pressure reader, a range of vital sign measurements (BP, pulse, weight, O2 sensor), and a digital health platform that provides patients and clinicians with key HF data.
The multi-center, prospective PROACTIVE-HF trial implanted the Cordella sensor in 528 NYHA class III HF patients (at 75 U.S. and European sites) and provided them and their clinicians with the Cordella platform. At six months, the trial met all primary safety and efficacy endpoints, and achieved key secondary endpoints:
- 99.2% freedom from device or system-related complications
- 99.8% freedom from PA sensor failure
- 0.15 HF hospitalization/all-cause mortality rate (well below 0.43 goal)
- 5-point improvement in KCCQ scores
- 23 meter improvement in 6-minute walk test
- 2.4 mmHg decrease in seated mean PA pressure
- 5.9 mmHg decrease in-office systolic blood pressure
- 2.2 lb decrease in at-home weight
These results were consistent across all patient sub-groups, and aligned with the Cordella Sensor’s 12-month data in the previous SIRONA 2 trial.
With these positive results on the books, Endotronix now awaits the FDA’s response to its PMA application, continues enrollment for its randomized and blinded PROACTIVE-HF 2 trial (the current trial was single-blinded and not randomized), and is preparing for its commercial launch later this year.
Once Endotronix commercially launches, it will have the benefits of an already-established market for PA pressure monitoring, noting that Abbott’s competing CardioMEMS system has been approved for a decade.
- In order to show differentiation once it does hit the market, Endotronix will rely on its unique abilities to involve patients with their HF data, measure a broad range of metrics, and to perform measurements while patients are seated (vs. lying down).
The Takeaway
Even if PA pressure-guided HF medication management is already well established, healthcare’s continued challenges with GDMT optimization suggest that there’s certainly room for new or improved solutions. Endotronix’s early messaging and trial results indicate that combining PA pressure with modern digital health approaches for “smart medication titration” might prove to be one of the GDMT-optimizing solutions we’ve been waiting for.
