WhiteSwell has reported encouraging clinical data from a trial of 21 patients treated with its innovative eLym system, a minimally invasive solution for fluid removal in acute decompensated heart failure (ADHF) patients. The results, presented at the Technology and Heart Failure Therapeutics (THT) meeting in Boston, demonstrate significant progress in addressing a critical medical need.
Clinical Trial Results and Patient Outcomes
The expanded cohort study, building upon earlier six-month feasibility data from nine patients, showed successful device deployment in all 21 hospitalized participants. Patients receiving eLym therapy in conjunction with diuretic treatment experienced substantial clinical improvements. The mean weight reduction from baseline to hospital discharge was 10.7 pounds, with all patients showing weight loss and demonstrating reduced peripheral edema and orthopnea.
Notably, kidney function remained stable throughout the treatment period and through discharge, a crucial consideration in heart failure management. The safety profile proved favorable, with only one patient experiencing a serious procedure-, device-, or therapy-related adverse event, which was resolved before discharge.
Innovative Technology and Mechanism
The eLym system represents a novel approach to treating ADHF through a catheter-based intervention. Deployed in the left internal jugular and innominate veins near the thoracic duct's connection point, the system creates a low-pressure zone that enhances fluid drainage when used alongside intravenous diuretics. This mechanism specifically targets the overwhelmed lymphatic system's ability to remove excess interstitial fluid from tissues and organs.
Regulatory Advancement and Future Plans
The FDA's decision to grant Breakthrough Device Designation and accept the eLym system into its Total Product Lifecycle Advisory Program (TAP) marks significant regulatory progress. WhiteSwell continues to expand its clinical trial sites and plans to initiate a randomized controlled trial across the United States, Canada, and Europe later this year.
Expert Perspectives
Dr. Jan Biegus, deputy scientific director at the Institute of Heart Diseases at Wroclaw Medical University in Poland, emphasized the significance of the results: "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. The 90-day rehospitalization rate of 9.5% with no deaths is substantially better than rates we see with standard-of-care diuretics alone."
Eamon Brady, WhiteSwell CEO, expressed optimism about the technology's potential impact: "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."
