The company also announced FDA breakthrough device designation for the system. The agency also accepted it into its Total Product Lifecycle Advisory Program (TAP).
Dr. Jan Biegus presented the data at the Technology and Heart Failure Therapeutics (THT) meeting in Boston. Biegus serves as deputy scientific director at the Institute of Heart Diseases at Wroclaw Medial University in Poland.
Galway, Ireland-based WhiteSwell designed eLym to treat acute decompensated heart failure (ADHF). The minimally invasive, catheter-based system aims to facilitate the removal of excess interstitial fluid from tissues and organs. It achieves this by supporting the overwhelmed lymphatic system in draining fluid for patients with ADHF.
eLym deploys in the left internal juglar and innominate veins, near where the lymphatic system’s thoracic duct connects. It creates a low-pressure zone, facilitating fluid drainage in conjunction with intravenous diuretics.
“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.”
A look at the findings from the WhiteSwell study
WhiteSwell previously reported six-month early feasibility data from nine patients treated with eLym in late 2023. The new data expands to a larger cohort of 21 hospitalized patients. They received eLym therapy in conjunction with diuretic therapy, with investigators following them through 90 days.
Investigators reported successful deployment in all 21 patients in the cohort. Patients who underwent eLym therapy plus loop diuretic lost a mean of 10.7 lbs from baseline to hospital discharge. Every patient lost weight and demonstrated resolution or reduction of peripheral edema and othopnea.
According to WhiteSwell, patients had stable kidney function during treatment and through discharge. One patient experienced a serious procedure-, device- or therapy-related adverse event. Investigators resolved this prior to discharge. At 90 days, 9.5% of patients experienced rehospitalization for heart failure. The study had no deaths.
The company says its study continues enrolling patients in Europe. It plans for a randomized controlled trial in the U.S., Canada and Europe later this year.
“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 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.”
