Endotronix Cordella Pulmonary Artery Sensor Meets Endpoints in PROACTIVE-HF Trial

March 5, 2024—Endotronix, Inc. announced the presentation of 6-month results from its PROACTIVE-HF pivotal trial. The study evaluated the company’s investigational Cordella pulmonary artery (PA) sensor in New York Heart Association (NYHA) class III heart failure (HF) patients at risk of congestion.

According to the company, the trial met primary safety and efficacy endpoints and demonstrated a markedly low rate of HF hospitalizations. Additionally, the data showed a clinically significant improvement in patient quality of life, increased physical activity, and improvement in the NYHA functional class.

Liviu Klein, MD, National Principal Investigator of the PROACTIVE-HF trial, presented the results during a late-breaking session at THT 2024, the Cardiovascular Research Foundation’s Technology and Heart Failure Therapeutics conference held March 4-6 in Boston, Massachusetts. Dr. Klein, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco in San Francisco, California.

In January, the company announced the submission of its FDA premarket approval application, which included the trial results. The study abstract from the THT meeting is available on the company’s website.

“These results are very encouraging and provide strong evidence in favor of HF management using PA pressure-guided therapy, along with vital sign data, to remotely optimize guideline-directed medical therapy and improve HF outcomes,” commented Dr. Klein in the company’s press release. “Cordella offers a novel patient-friendly system that includes a handheld PA pressure reader and allows patient visibility to health data.”

Dr. Klein continued, “In my opinion, these key differentiators helped drive high levels of engagement for patients and supported them to make healthy lifestyle choices. Combined with the clinicians’ targeted medication adjustments using the system’s comprehensive view of patient health status, we achieved great patient outcomes overall and when compared to the same period before sensor implant.”

As summarized by Endotronix, the multicenter, prospective trial implanted 528 NYHA class III HF patients across 75 sites in the United States and Europe. More than half of the implanters were HF specialists.

The trial showed high rates of patient compliance (> 6 average Cordella submissions per week) and clinician engagement (> 2 average reviews per week).

The 6-month single-arm results met primary safety and efficacy endpoints as well as several clinically significant secondary efficacy endpoints as follows:

• Freedom from device or system-related complications was 99.2%.
• Freedom from PA sensor failure was 99.8%.
• The rate of HF hospitalization/all-cause mortality at 6 months was low at 0.15 compared to a performance goal of 0.43 based on previous PA pressure-guided HF management trials (P < .0001). Primary efficacy was met across all subgroups of PA pressure-guided HF management (P < .0001).
• Clinically significant improvement in patient quality of life metrics and key health metrics: five-point improvement in Kansas City Cardiomyopathy Questionnaire (P < .0001); 23-meter improvement in 6-minute walk test (P = .001); 144 patients improved their NYHA class designation (P < .0001); 2.4 mm Hg decrease in seated mean PA pressure from baseline for congested patients (P = .001); 5.9 mm Hg decrease in-office systolic blood pressure from baseline (P < .0001); and 2.2-pound decrease in at-home weight (P = .001).

The company noted that PROACTIVE-HF results are consistent with previously reported clinical data for the Cordella PA sensor, including the 12-month results from the SIRONA 2 trial that were presented last May at Heart Failure 2023, the European Society of Cardiology’s annual conference and published online in ESC Heart Failure in January 2024.

In addition, Endotronix continues to extend its evidence-based clinical foundation for Cordella with the market-expanding PROACTIVE-HF-2 clinical trial, which is enrolling patients. The company announced approval of an investigational device exemption for the study in October 2023.

The Cordella PA sensor system is an investigational device and is not currently approved for clinical use in any geography. The Cordella HF system, without the sensor, is available for commercial use in the United States and the European Union.