Reprieve Study Holds Promise for ADHF CareReprieve Study Holds Promise for ADHF Care

Reprieve Cardiovascular today announced results for its first-in-human study of the Reprieve system for the treatment of acute decompensated heart failure (ADHF). The study focused on the device’s safety and efficacy for ADHF.

ADHF can manifest as a sudden or gradual onset of symptoms like difficulty breathing, leg or feet swelling, and fatigue. In turn, the condition often requires unplanned doctor’s office visits, emergency room care, or hospitalizations, with an average stay of more than five days. Fluid volume management can be a consistent challenge for ADHF patients, as nearly one in four are readmitted to the hospital within 30 days to address fluid volume overload, and approximately half are readmitted within six months.

The primary treatment to manage fluid for ADHF cases is the use of diuretics. However, diuretics are difficult to administer precisely without real-time information on patient response, according to the company. This imprecise procedure can lead to an increased risk of kidney injury, prolonged hospital stays, inadequate fluid removal at discharge, and frequent readmissions.

In response to patient need, Reprieve Cardiovascular said it developed its namesake device to personalize decongestion management and, “remove fluid and sodium through precise administration of diuretics, rapidly finding the optimal dose while delivering the necessary volume of fluid and sodium to support optimal kidney function,” according to the press release.

Related:Wellumio Develops Portable Stroke Detection Device

To do this, the Reprieve system combines real-time physiological monitoring with automated recommendations to escalate or end therapy for individual patient need.

Its first-in-human, open-label, single-arm study to evaluate the device’s ability to optimally decongest patients with ADHF was held in Tbilisi, Georgia, and included 10 participants. In the study, patients received Reprieve treatment until completion of therapy, or for a maximum of 72 hours, whichever came first. Follow-up clinical assessments were performed during- and post-treatment through 30 days after being discharged. Additionally, any adverse events were assessed for 30 days post-treatment.

The system met its primary efficacy endpoint of functional device success, which the company defined as “the device's ability to perform its intended function as specified in the study protocol without any device-related adverse events or malfunctions as determined by the treating physician over the 72-hour maximum duration of therapy.”

Successfully facilitating high-volume fluid and sodium removal, with an average treatment duration of 18.3 hours, the study recorded a net fluid loss of approximately 4.8L, an average weight reduction of 4.8 kg, and a net sodium loss of 653 mmol.

Related:Philips Faces a Different Kind of Recall in 2025

Study participants’ kidney function remained stable, with none developing acute kidney injury, and the average serum creatinine level decrease over the course of therapy. This indicated, “effective decongestion without renal complications. No device or procedure related adverse events were reported through 30 days,” according to the release.

Earlier this year, the company also completed enrolment for its US FASTR pilot trial and expects study results in early 2025, said Mark Pacyna, CEO of Reprieve Cardiovascular, in the release.

"We are encouraged by these initial results from the first-in-human study of the Reprieve system, which demonstrate its potential to enable clinicians to manage fluid overload safely and efficiently," Pacyna said. "We know greater sodium removal improves short and long-term outcomes for ADHF patients. We were also thrilled to complete enrollment in our U.S. FASTR pilot trial earlier this year and look forward to sharing those results in early 2025, with the goal of further validating the findings from this First-In-Human study of the Reprieve system. Looking ahead, we aim to prove the full potential of the Reprieve system in a global pivotal study next year, marking an important step toward our mission of transforming decongestion management for acute heart failure patients."

Related:J&J Halts PFA Cases Amid Stroke Reports