WhiteSwell announced positive initial results from its DELTA-HF trial evaluating its eLym system for excess fluid removal.
Galway, Ireland-based WhiteSwell designed eLym to treat acute decompensated heart failure (ADHF). It presented data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023 in Cleveland, Ohio.
The study evaluates the eLym minimally invasive catheter-based system. eLym facilitates the removal of excess fluid from the body’s tissues and organs concurrent with diuretic removal of excess vascular fluid. The system targets the body’s largest lymphatic vessel and creates pressure conditions. These conditions support the tissue drainage capabilities of the overwhelmed lymphatic system.
Clinicians deploy e the left internal jugular and innominate veins near the thoracic duct. It creates a low-pressure zone to facilitate fluid drainage in conjunction with intravenous diuretics.
In DELTA-HF, nine hospitalized patients received eLym therapy in conjunction with diuretic therapy. Six patients received the standard-of-care treatment with loop diuretics alone.
Key findings include that eLym proved safe and successful with a mean treatment time of 24 hours. No patient experienced serious procedure-, device-, or therapy-related adverse event.
Early clinical results show a mean loss of 6.0±4.6 kg from baseline to hospital discharge while maintaining kidney function. The loop diuretic-only group lost a mean of 3.3±3.7 kg. WhiteSwell reports one hospitalization within 30 days of discharge.
“This is a new approach, and we are excited to investigate WhiteSwell’s catheter-based system,” said Dr. Zviad Kereselidze, head of the ICCU at Tbilisi Heart Center. “We have treated some of our most challenging patients who are frequently hospitalized 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.”