WhiteSwell’s eLym System Evaluated in DELTA-HF, Receives FDA Breakthrough Device Designation

February 13, 2025—WhiteSwell announced Jan Biegus, MD, presented new data from the DELTA-HF trial on the company’s eLym system at the 2025 Technology and Heart Failure Therapeutics (THT) meeting. The data showed eLym was successfully deployed in all 21 patients in the cohort. 

“The eLym System is designed to support lymphatic function during decongestive therapy,” commented Dr. Biegus in WhiteSwell’s announcement. “In the first 21 patients treated, all patients lost weight and demonstrated concordant signs of decongestion, while maintaining stable renal function.”

According to the company, patients who underwent therapy with the eLym system plus loop diuretic lost a mean of -10.7 lbs (± 7.1) from baseline to hospital discharge, with every patient losing weight and demonstrating resolution or reduction of peripheral edema and orthopnea. Additionally, kidney function was stable during treatment and through discharge, as measured by creatinine (mean Δ 0.02 ± 0.26 mg/dL).

After 90 days, there were no deaths and only two patients had been rehospitalized for heart failure. Dr. Biegus commented “At 90 days, having just 9.5% of patients rehospitalized for heart failure with no deaths is substantially better than rates we see with standard-of-care diuretics alone, which is quite promising,” Dr. Biegus is Deputy Scientific Director at the Institute of Heart Diseases at Wroclaw Medical University in Wrocław, Poland.

DELTA-HF, a non-randomized early feasibility trial evaluating the safety and performance of the eLym System in the treatment of fluid overload or congestion in patients with acute decompensated heart failure (ADHF), continues to enroll patients in Europe. WhiteSwell noted that a randomized controlled trial will start later this year in the United States, Canada, and Europe. 

The company also announced that the eLym system was granted Breakthrough Device designation from the United States FDA. WhiteSwell describes the eLym system as a minimally invasive, catheter-based system designed to remove excess fluid from tissues and organs in patients with ADHF by supporting the overwhelmed lymphatic system in draining fluid.