WhiteSwell’s eLym System Studied for Treating Acute Decompensated Heart Failure

March 6, 2024—WhiteSwell announced 6-month follow-up data on initial patients with acute decompensated heart failure (ADHF) treated in its ongoing DELTA-HF trial.

DELTA-HF is a nonrandomized early feasibility trial evaluating the safety and performance of WhiteSwell’s eLym system for the treatment of fluid overload or congestion in patients with ADHF. The minimally invasive, catheter-based device is intended to facilitate fluid removal from the body’s tissues and organs, concurrent with diuretic removal of excess vascular fluid. The device targets the thoracic duct and creates pressure conditions that support the tissue drainage capabilities of the overwhelmed lymphatic system.

The data were presented by William Abraham, MD, at THT 2024, the Technology and Heart Failure Therapeutics conference held March 4-6 in Boston, Massachusetts.

According to the company, nine hospitalized patients with ADHF received eLym therapy in conjunction with diuretic therapy. The eLym system was successfully deployed and removed in all patients, with a mean treatment time of 24 hours. The patients were followed for 6 months.

Investigators found that eLym therapy resulted in reduced tissue congestion—CA-125 decreased by 77% from baseline to a median of 23 u/ml at 90 days. Additionally, there was a 77% reduction in hospitalizations. In the 6 months before eLym therapy, there were 13 heart failure-related hospitalizations. In the 6 months after eLym therapy, there were two heart failure hospitalizations and one heart failure–related death.

At hospital discharge, acute decongestion was demonstrated by a mean weight loss of approximately 6 kg, the elimination of orthopnea, and the reduction of peripheral edema in all patients. Kidney function was preserved in all patients during treatment and out to 30 days. The treatment was safe with no serious procedure-, device- or therapy-related adverse events in eight of nine patients.

“These data demonstrate that the eLym system is safe and, in conjunction with loop diuretics, can support consistent improvement of multiple markers of decongestion, all while preserving renal function,” commented Dr. Abraham in the WhiteSwell press release.

Dr. Abraham, Professor of Medicine, Physiology, and Cell Biology at The Ohio State University Wexner Medical Center in Columbus, Ohio, continued, “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. I look forward to additional clinical data building upon these findings.”

George Khabeishvili, MD, Principal Investigator for DELTA-HF at Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia, added, “We have patients with ADHF who are frequently hospitalized with congestion, and they are very challenging to treat. The unique treatment approach with the eLym system involves a straightforward procedure. The therapy has helped my patients feel better and, importantly, helped keep them out of the hospital.”