WhiteSwell Announces New Data Supporting Acute Decompensated Heart Failure Treatment with eLym System
eLym System recently received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA)
GALWAY, Ireland, February 13, 2025--(BUSINESS WIRE)--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."
About the DELTA-HF Trial
The Decongestion of Excess Lymphatic Fluid via the Thoracic Duct in Acute Decompensated Heart Failure (DELTA-HF) Trial is 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 ADHF. A study design manuscript was recently published (Biegus et al, Design and Rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure [DELTA-HF]. ESC Heart Fail. 2024 Dec 24. DOI: 10.1002/ehf2.15192).
About the eLym™ System
The eLym System is a minimally invasive, catheter-based system designed to facilitate the removal of excess fluid from tissues and organs (interstitial fluid) in patients with ADHF by supporting the overwhelmed lymphatic system in draining fluid. The eLym System is deployed in the left internal jugular and innominate veins near where the lymphatic system's major highway, the thoracic duct, connects. It creates a low pressure zone to facilitate fluid drainage in conjunction with intravenous diuretics.
About Acute Decompensated Heart Failure (ADHF)
ADHF is an episode of worsening heart failure symptoms that results in millions of hospitalizations worldwide each year, including three million in the U.S. alone.1 Patients with ADHF experience difficulty breathing, fatigue, and edema (swelling) due to fluid back-up in the lungs and other parts of the body (congestion). The condition requires hospital-based treatment to remove excess fluid in a process called decongestion. Complete decongestion is the goal of ADHF treatment, since residual congestion at hospital discharge is the strongest predictor of rehospitalization and death.2 As many as half of ADHF patients are discharged from the hospital not fully decongested, and one out of four ADHF patients is readmitted to the hospital within one month.3,4,5
About the Lymphatic System and ADHF
In healthy individuals, the lymphatic system continuously captures fluid from tissues throughout the body and pumps it back into the vascular system to maintain homeostasis. In ADHF, excess fluid collects in the tissues of the body (the interstitial compartment) causing edema and an increase in venous blood pressure. Excess tissue fluid and high venous blood pressure interfere with the lymphatic system's ability to move fluid back to the vascular system, which can further exacerbate congestion.
About WhiteSwell
WhiteSwell is a patient-focused company dedicated to improving treatment of acute decompensated heart failure (ADHF), a primary cause of repeat hospitalization and emergency room visits. A privately held company, WhiteSwell is headquartered in Galway, Ireland. For more information visit www.whiteswell.com.
1 Hollenberg et al., J Am Coll Cardiol 2019;74:1966–2011. (1M annual hospital discharges with HF as primary diagnosis and 2M hospital discharges with HF as secondary contributing diagnosis.)2 Martens & Mullens, How to tackle congestion in acute heart failure, Korean J Intern Med 2018;33:462-4733 Girerd et al, Integrative Assessment of Congestion in Heart Failure Throughout the Patient Journey, J Am Coll Cardiol HF 2018;6:273–854 Arrigo et al, Nature Reviews Disease Primers volume 6, Article number: 16 (2020)5 Rubio-Gracia, J. et al. (2018). International Journal of Cardiology, 258, pp. 185-191.
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