WhiteSwell’s eLym System delivers promising results in early feasibility study in ADHF
09 Oct 2023
Clinical StudyAHA
The DELTA-HF is a non-randomised study with a goal to assess the safety and performance of eLym to treat fluid overload or congestion in patients with ADHF
The eLym System is a minimally invasive catheter-based system. (Credit: Robina Weermeijer on Unsplash)
Ireland-based WhiteSwell has reported successful treatment of acute decompensated heart failure (ADHF) patients using the WhiteSwell eLym System in an early feasibility DELTA-HF study.
The eLym System is a minimally invasive catheter-based system. It is intended to enable the removal of surplus fluid from tissues and organs in ADHF patients along with diuretic removal of excess vascular fluid.
DELTA-HF is a non-randomised study with the goal of assessing the safety and performance of eLym to treat fluid overload or congestion in patients with ADHF.
During the trial, nine hospitalised patients were administered with eLym therapy in conjunction with diuretic therapy. Six patients were given standard of care treatment with loop diuretics alone.
As per the findings of the study, the treatment with eLym was found safe and successful. It was used and activated in nine patients with a mean treatment time of 24 hours.
In addition, no patient faced a serious procedure-, device-, or therapy-related adverse events.
WhiteSwell, which is focused on developing treatments for ADHF patients, said that the early clinical results are promising and back further clinical assessment.
The patients who underwent therapy with the eLym System plus loop diuretic showed 6.0±4.6 kg loss from baseline to hospital discharge while preserving kidney function, as evaluated by a stable or improved creatinine.
The group with loop diuretic-only lost a mean of 3.3±3.7 kg and one treated patient was hospitalised within one month of discharge.
Tbilisi Heart Center ICCU head Zviad Kereselidze said: “This is a new approach, and we are excited to investigate WhiteSwell’s catheter-based system.
“We have treated some of our most challenging patients who are frequently hospitalised with congestion, and we have been pleasantly surprised with how well they have decongested at the time of discharge and how the benefit was sustained at 30-day follow-up.”
The Irish company has plans to continue evaluating the system in ADHF patients’ treatment with continued enrolment and follow-up in the DELTA-HF trial.
Additional findings from the study are expected in the future.
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