WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive data from 21 patients treated in its DELTA-HF trial evaluating the WhiteSwell eLym System. The data were presented at the Technology and Heart Failure Therapeutics (THT) meeting in Boston by Jan Biegus, M.D., deputy scientific director at the Institute of Heart Diseases at Wroclaw Medical University in Poland.
“Persistent congestion in acute heart failure patients is associated with a high risk of rehospitalization and death. The lymphatic system is believed to be critical in effectively removing excess fluid from the tissues and organs, yet can be dysfunctional in heart failure patients,” said Dr. Biegus. “The eLym System is designed to support lymphatic function during decongestive therapy. In the first 21 patients treated, all patients lost weight and demonstrated concordant signs of decongestion, while maintaining stable renal function. 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.”
WhiteSwell previously reported early feasibility data studying nine patients treated with the eLym System and followed those patients through six months. The newly-presented data expand to a larger cohort of 21 hospitalized patients who received eLym therapy in conjunction with diuretic therapy and were followed through 90 days.
Summary of key findings:
- The device was deployed successfully in all 21 patients in the study cohort.
- 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.
- Kidney function was stable during treatment and through discharge, as measured by creatinine (mean Δ 0.02 ± 0.26 mg/dL).
- One patient experienced a serious procedure-, device- or therapy-related adverse event, which resolved prior to discharge.
- At 90 days, 9.5% of patients were rehospitalized for heart failure and there were no deaths.
The DELTA-HF feasibility study is continuing to enroll patients in Europe. A randomized controlled trial will begin in the United States, Canada and Europe later this year.
WhiteSwell also announced that the eLym System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This prioritizes the review process for novel technologies that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The company has also been accepted into the Total Product Lifecycle Advisory Program (TAP), which the FDA has established to expedite patient and physician access to innovative medical devices.
“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 randomized controlled trial in the U.S. and other countries,” said Eamon Brady, WhiteSwell CEO. “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 hospitalizations for people with ADHF and improve patient outcomes.”
