GALWAY, Ireland, May 10, 2026
WhiteSwell announced positive primary clinical results from the DELTA-HF feasibility trial evaluating its investigational eLym™ System for patients suffering from acute decompensated heart failure (ADHF), one of the leading causes of cardiovascular hospitalization globally. The data were simultaneously presented at the Heart Failure 2026 Congress organized by the Heart Failure Association of the European Society of Cardiology in Barcelona and published in the European Journal of Heart Failure, highlighting growing clinical interest in lymphatic-system-targeted therapies for severe heart failure management.
The six-month data from 40 treated patients demonstrated meaningful decongestion outcomes, preserved kidney function, and reduced rates of rehospitalization and death, supporting continued clinical development of the company’s novel catheter-based technology. According to the study findings, patients treated with the eLym System achieved a mean weight loss of 6.8 kilograms during hospitalization, while 82.5% remained free from heart failure hospitalization or death at six months. WhiteSwell stated that the encouraging safety and efficacy signals support plans to initiate the randomized pivotal LYMPH-HF trial later in 2026 across the United States, Canada, Europe, and Israel.
DELTA-HF Trial Demonstrates Effective Decongestion and Stable Renal Function
The DELTA-HF study was designed as a multicenter, single-arm early feasibility clinical trial evaluating the safety and performance of the investigational eLym System in hospitalized ADHF patients experiencing significant fluid overload despite aggressive standard diuretic therapy. The enrolled patient population represented a particularly high-risk group with multiple co-morbidities and poor responsiveness to conventional treatment approaches. The eLym System works by creating a localized low-pressure zone near the thoracic duct outflow using an endovenous micro-axial impeller pump, supporting enhanced lymphatic drainage and removal of excess interstitial fluid accumulation.
Patients in the study received treatment with the device for an average duration of approximately 23 hours in combination with standard intravenous diuretic therapy. Clinical findings demonstrated substantial decongestion benefits, with the median modified EVEREST Clinical Congestion Score improving from 5.0 at baseline to 0 by discharge and remaining stable through six months of follow-up. Importantly, renal function remained stable throughout treatment, with serum creatinine levels slightly improving following therapy — a critical consideration in advanced heart failure management where aggressive fluid removal often compromises kidney function. Device deployment was successful in 100% of treated patients, and thoracic duct pressure reduction was achieved in 98% of cases.
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Novel Lymphatic-Based Therapy Targets Major Heart Failure Treatment Gap
WhiteSwell’s investigational eLym System represents a differentiated approach to treating acute heart failure by directly targeting dysfunction within the lymphatic system rather than relying solely on intensified diuretic therapy. In patients with ADHF, congestion occurs when excess fluid accumulates in tissues and organs due to the heart’s inability to pump effectively, leading to shortness of breath, swelling, kidney impairment, and repeated hospitalization. Traditional therapies primarily focus on increasing urinary fluid removal using diuretics, but many patients experience incomplete decongestion or become resistant to these medications. WhiteSwell’s technology is designed to restore lymphatic drainage capacity and improve removal of interstitial fluid, potentially addressing one of the underlying physiologic mechanisms contributing to persistent congestion.
Study investigators highlighted the significance of the six-month outcomes, particularly given the severe disease burden among enrolled patients. Principal Investigator Dr. William T. Abraham of The Ohio State University noted that event rates among poor diuretic responders can reach nearly 50% within six months, making the observed 82.5% freedom from hospitalization and death especially notable. Researchers also reported sustained symptomatic improvement following bedside device removal, suggesting the therapy may provide clinically meaningful decongestion benefits beyond the immediate treatment period.
WhiteSwell Advances Toward Global Pivotal Clinical Development
The positive DELTA-HF findings strengthen WhiteSwell’s position within the rapidly evolving cardiovascular device sector focused on improving outcomes in heart failure patients with limited treatment options. Acute decompensated heart failure remains one of the largest unmet medical needs in cardiovascular medicine, contributing to millions of hospital admissions annually and carrying extremely high readmission and mortality rates. Residual congestion following discharge is considered one of the strongest predictors of rehospitalization and death, yet many patients leave the hospital incompletely decongested despite aggressive treatment.
WhiteSwell believes its lymphatic-focused therapeutic strategy could potentially redefine standard heart failure management by complementing existing drug therapies with a mechanical decongestion platform. The company’s eLym System has already received FDA Breakthrough Device Designation, providing potential regulatory advantages as development advances. With the upcoming LYMPH-HF randomized pivotal study expected to launch later this year, WhiteSwell is positioning itself among a new generation of cardiovascular innovators developing device-based solutions aimed at improving long-term outcomes for patients with advanced heart failure.
Source: WhiteSwell press release
