Endotronix Nets IDE Approval for PROACTIVE-HF 2 Study

Endotronix has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for a subsequent PROACTIVE-HF 2 study to evaluate the company’s Cordella sensor for pulmonary artery (PA) pressure-guided therapy.
 
The company says the prospective, dual-arm trial’s goal is to broaden access to New York Heart Association (NYHA) class II heart failure (HF) patients and support efficient, scalable remote patient management with a clinician-directed, patient self-management strategy.
 
PROACTIVE-HF 2 will enroll up to 1,500 patients in the U.S. and Europe. The randomized arm will assess safety and efficacy of PA pressure-guided therapy with Cordella in NYHA class II patients at risk of congestion. In both cohorts, there will be access to daily, trended telehealth data (blood pressure, heart rate, and weight).
 
The study will evaluate safety and efficacy, using a compositive first HF event or death rate, for up to 24 months. The single-arm study will assess the impact of clinician-directed patient self-management at home in NYHA class III HF patients who are at risk for poor outcomes using a 12-month endpoint for safety and incidence of HF hospitalization or death.
 
Additionally, the company presented 12-month sub-study data from its initial pivotal PROACTIVE-HF trial at the Heart Failure Society of America (HFSA) conference, demonstrating a low HF hospitalization rate of 0.34 at 12 months in NYHA class III HF patients. 
 
“We are establishing a strong foundation of compelling clinical evidence for Cordella with early PROACTIVE-HF data. The team is driving towards PMA submission before the end of this year and looks forward to sharing the results from the full study cohort in 2024,” Endotronix’s CEO and co-founder Harry Rowland told the press. “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.”