Rochester General Hospital (RGH) has become the first site in the United States to launch a pivotal clinical trial of the AquaPass system, a device designed to alleviate fluid overload in patients with congestive heart failure and end-stage renal disease. This marks a significant step forward in exploring non-invasive treatments for a condition that frequently leads to hospitalization.
William Licherdell, a resident of Greece, NY, was the first U.S. patient to use the AquaPass suit for congestive heart failure under the supervision of Scott Feitell, DO, Director of Heart Failure at Sands-Constellation Heart Institute at RRH and the Principal Investigator for the trial in the United States.
AquaPass: A Novel Approach to Fluid Overload
Fluid overload is a primary cause of hospitalization for individuals with congestive heart failure. The condition arises when the heart's ability to pump blood effectively is compromised, leading to increased pressure in blood vessels and subsequent swelling in the extremities and abdomen. Fluid accumulation in the lungs further exacerbates the issue, causing shortness of breath and potentially life-threatening complications.
The AquaPass system offers a unique solution by employing a non-invasive method to remove excess fluid. The device, worn as a robe, utilizes warm air to evaporate and extract fluid through the skin without significantly raising body temperature. This approach is renal-independent and drug-free, presenting a potential alternative for patients who may not respond well to traditional diuretic therapies.
Promising Results from Initial Trials
Clinical trials conducted in Israel have yielded promising results, demonstrating a reduction in fluid weight among all participating patients. Furthermore, a 30% decrease in diuretic drug use was observed in these patients, and nearly half reported an improvement in their overall quality of life. Notably, there were no hospital readmissions during the trial period.
"We are excited at Rochester Regional Health to work on a clinical trial that could one day offer all of our heart failure patients a non-invasive renal independent therapy focused on improving their quality of life," said Dr. Feitell. "We’re proud to be a part of the process driving innovation, and offering cutting-edge technology that could provide new hope for those trying to manage the symptoms of their disease."
Path to FDA Approval and Wider Availability
The ongoing study at RGH is crucial for securing FDA market approval for the AquaPass system in the U.S. If successful, AquaPass could offer a cost-effective means of managing fluid overload symptoms in heart failure patients within the comfort of their homes, potentially reducing the need for expensive and prolonged hospital stays. The trial is currently enrolling patients, marking an important phase in the device's development and potential widespread adoption.
