WhiteSwell has announced positive data from 21 patients treated in the DELTA-HF trial evaluating the WhiteSwell eLym system.
The data were presented at the Technology and Heart Failure Therapeutics (THT) meeting (11–13 February, Boston, USA) by Jan Biegus, deputy scientific director at the Institute of Heart Diseases at Wroclaw Medical University (Wrocław, Poland).
The eLym system is a minimally invasive, catheter-based system designed to facilitate the removal of excess fluid from tissues and organs in patients with acute decompensated heart failure (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.
“Persistent congestion in acute heart failure patients is associated with a high risk of rehospitalisation 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 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 rehospitalised 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 hospitalised patients who received eLym therapy in conjunction with diuretic therapy and were followed through 90 days.
Findings of the study showed that the device was deployed successfully in all 21 patients in the study cohort, and patients who underwent therapy with the eLym system plus loop diuretic lost a mean of -10.7lbs (±7.1) from baseline to hospital discharge, with every patient losing weight and demonstrating resolution or reduction of peripheral oedema and orthopnoea.
Kidney function was stable during treatment and through discharge, as measured by creatinine (mean Δ0.02 ± 0.26mg/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 rehospitalised for heart failure and there were no deaths.
The DELTA-HF feasibility study is continuing to enrol patients in Europe. A randomised controlled trial will begin in the USA, Canada and Europe later this year.
WhiteSwell also announced that the eLym system has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). This prioritises 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 randomised controlled trial in the USA 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 hospitalisations for people with ADHF and improve patient outcomes.”
