WhiteSwell has reported encouraging results from its DELTA-HF trial, which evaluated the minimally invasive catheter-based eLym System in treating individuals with acute decompensated heart failure (ADHF).
The study involved 21 hospitalised subjects who received the eLym therapy alongside diuretic treatment and were monitored for up to 90 days.
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The eLym System was deployed in all subjects, with each one experiencing weight loss and showing improvement in peripheral oedema and orthopnoea. Mean weight loss from baseline to hospital discharge was -10.7lb (±7.1).
Kidney function was observed to remain stable during and after treatment, as indicated by a mean creatinine change of 0.02mg/dL ± 0.26mg/dL.
At the 90-day mark, the rehospitalisation rate for heart failure was 9.5%, and there were no reported deaths.
WhiteSwell CEO Eamon Brady said: “We are encouraged by the clinical results as more patients are treated with the eLym System. WhiteSwell is entering an important phase as we expand our clinical trial sites and look ahead to a randomised controlled trial in the US and other countries.
“By supporting the lymphatic system to drain interstitial tissues and organs in conjunction with diuretic therapy, we hope to break the cycle of repeated heart failure hospitalisations for people with ADHF and improve patient outcomes.”
The feasibility study is currently enrolling subjects across Europe, with plans for a randomised controlled trial to commence later in the year in Canada, Europe, and the US.
Designed to aid in the elimination of excess interstitial fluid in ADHF individuals by supporting the overwhelmed lymphatic system, the eLym system has achieved breakthrough device designation from the US Food and Drug Administration (FDA).
The FDA also accepted WhiteSwell into its Total Product Lifecycle Advisory Program (TAP) to accelerate access to this medical device.
Deployed in the left internal jugular and innominate veins, the system creates a low-pressure zone that works in conjunction with intravenous diuretics to enhance fluid drainage.
