Endotronix has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for the PROACTIVE-HF 2 trial of its Cordella Sensor for pulmonary artery (PA) pressure-guided therapy.

The Cordella Sensor is designed to be an implantable PA pressure sensor for measuring the main indicator of congestion to enable early and targeted therapy.

PROACTIVE-HF 2 is a prospective, dual-arm, open-label, randomised controlled trial. It intends to expand access to New York Heart Association (NYHA) class II heart failure (HF) patients.

It is also designed to aid efficient and scalable remote patient management with a clinician-directed, self-management plan.

Endotronix CEO and co-founder Harry Rowland said: “We are establishing a strong foundation of compelling clinical evidence for Cordella with early PROACTIVE-HF data. The team is driving towards pre-market approval (PMA) submission before the end of this year and looks forward to sharing the results from the full study cohort in 2024.

“We remain confident in the benefits Cordella brings to patients and clinicians to improve heart failure outcomes and remain on track for a mid-2024 launch.”

The US-based digital health and medical technology firm plans to register up to 1,500 patients in the US and Europe for the trial. The first patient’s enrolment is expected later this year.

The trial’s randomised arm will assess the efficacy and safety of PA pressure-guided therapy using Cordella in NYHA class II patients who are prone to congestion.

Endotronix said that in both cohorts, clinicians and patients will have access to daily trended telehealth data. In addition, the treatment arm can also access daily PA pressure data.

PROACTIVE-HF 2 will evaluate the safety and efficacy, using a compositive first HF event or death rate, for up to 24 months.

The single-arm study will assess the effect of clinician-directed patient self-management. It will use a 12-month endpoint for safety and incidence of HF hospitalisation or death.

Both cohorts will also gather data on the secondary endpoint, including changes in right ventricular function in terms of PA pressure, the medical technology firm added.

Furthermore, Endotronix announced 12-month sub-study data from its initial PROACTIVE-HF trial which showed a low HF hospitalisation rate of 0.34 at 12 months in NYHA class III HF patients.

The firm is planning for a PMA submission to the FDA by the end of this year.