WhiteSwell has revealed positive six-month outcomes for patients with acute decompensated heart failure (ADHF), treated with its eLym System, as part of the ongoing DELTA-HF trial.
The DELTA-HF trial is a non-randomised early feasibility study assessing the eLym System’s safety and performance.
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The eLym System is a minimally invasive catheter-based system. It is designed to allow the removal of excess fluid from tissues and organs (interstitial fluid) in patients with ADHF.
Initially, nine patients were treated who demonstrated a significant reduction in heart failure-related hospitalisations post-therapy.
The findings were shared by the Ohio State University Wexner Medical Center medicine, physiology, and cell biology professor William Abraham.
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Hospitalised with ADHF, the nine patients underwent eLym therapy alongside diuretic treatment. They were monitored for six months.
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By GlobalDataA notable biomarker of tissue congestion, CA-125, reduced by 77% to a median of 23u/ml at 90 days.
Comparatively, in the six months before eLym therapy, there were 13 heart failure hospitalisations, which dropped to just two following the treatment, alongside one heart failure-related death.
The eLym System was successfully deployed and removed in all patients, with an average treatment duration of 24 hours.
Upon discharge, patients exhibited acute decongestion, evidenced by an average weight loss of around 6kg, resolution of orthopnea, and reduced peripheral oedema.
Abraham said: “These data demonstrate that the eLym System is safe and, in conjunction with loop diuretics, can support the consistent improvement of multiple markers of decongestion, all while preserving renal function.
“We were especially encouraged by the dramatic reductions in heart failure-related events, which were reduced despite no up-titration of guideline-directed medical therapy.”
