WhiteSwell has debuted promising early data from a feasibility study on its eLym system in acute decompensated heart failure (ADHF), though a treatment-related patient death may prompt questions around the safety of its fitting.
In the ongoing single-arm DELTA-HF trial (NCT05747196), 40 adults with ADHF are being treated with the eLym system alongside standard of care (SoC) diuretic therapies. All patients enrolled on this trial have had an insufficient response to diuretics in the past, as well as multiple comorbidities.
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Six months after treatment with the device, 82.5% of patients remained free from heart failure-prompted hospitalisation, while eLym lowered thoracic duct pressure in 98% of cases.
Meanwhile, the treatment cohort reached a median modified EVEREST clinical congestion score of 0, which indicates no congestion caused by blood returning to the heart faster than the heart can pump it back out to the body. Following treatment, patients lost an average of 6.8kg (15lbs) at the six-month mark.
WhiteSwell has designed the eLym system to treat ADHF alongside diuretics by restoring lymphatic flow to diminish congestion. The device acts by creating a region of low pressure in the thoracic duct, a lymph draining system local to the chest, meaning that fluid can more freely flow through the lymphatic system for removal.
Data from the DELTA-HF trial was presented at the ongoing 2026 Heart Failure Congress held by the European Society of Cardiology’s (ESC) Heart Failure Association in Barcelona, which is being held between 9-12 May.
Addressing safety concerns
While the eLym system may have shown promising preliminary efficacy at both the 90-day and six-month timestamps, a patient death could raise concerns around the safety of the device’s administration.
In a statement to Clinical Trials Arena on the death, WhiteSwell’s Sergio Shkurovich, VP Clinical Affairs, said: “As disclosed in the DELTA-HF results, one patient experienced a procedure-related serious adverse event that resulted in death.”
“In this case, a vascular complication occurred during the access procedure prior to introduction of the investigational device. The company took this event very seriously and performed a thorough investigation and has supplemented training to mitigate risk.”
The patient suffered a haematoma within the mediastinum – the region between the lungs that contains vital organs like the heart and oesophagus.
Alongside this death, another patient experienced a serious case of low blood pressure, which resolved after treatment.
Following the results of this study, WhiteSwell is planning to start the randomised LYMPH-HF trial further into 2026, which the company says will take place across sites in the US, Europe, Canada and Israel.
To mitigate further risks in this study, Shkurovich noted that WhiteSwell will focus on independent safety oversight and rigorous monitoring, while ensuring the use of predefined safety endpoints and ongoing reviews by investigators and regulators.
“WhiteSwell and the oversight committee agree that conducting a randomised controlled trial is the appropriate next step to fully evaluate the therapy’s benefit-risk profile in patients with ADHF,” Shkurovich added.
Doctors and patients will likely welcome new approaches to treating ADHF as, according to a paper published in the journal Circulation Research, around one in six admitted for heart failure die within 30 days of hospitalisation.
