MINNEAPOLIS – Pleural Dynamics has completed enrollment in its post-market clinical study of the ACES Automatic Continuous Effusion Shunt System, a novel fully implantable device designed to provide continuous relief for patients suffering from recurrent pleural effusions. The final patient was enrolled at Memorial Regional Hospital in Hollywood, Florida.
The ACES system, cleared by the U.S. Food and Drug Administration in August 2023, is the first fully implantable device that uses the natural motion of breathing to remove excess fluid from the chest cavity. Unlike standard treatments, it does not require an external catheter, repeated drainage into canisters, or extended hospital stays. Instead, the one-piece device transfers fluid from the chest into the abdomen, where it can be reabsorbed by the body.
Traditional approaches to treating pleural effusion—such as pleurodesis or indwelling pleural catheters—often involve painful procedures, long hospital stays, or ongoing maintenance. Pleural Dynamics aims to address these challenges with its minimally invasive implant, which can improve breathing and reduce discomfort for patients whose conditions are often complicated by cancer or other chronic diseases.
“We’re thrilled to have participated in this study of the ACES device and to have been the center to enroll the last patient,” said Dr. Mark Block, chief of thoracic surgery at Memorial Healthcare System. “This marks a major step toward understanding how this device can improve not only clinical outcomes but also the day-to-day quality of life for these patients.”
The prospective, multi-center study enrolled 25 patients across four U.S. hospitals. Participants are being monitored for changes in fluid volume, shortness of breath, quality of life, and healthcare utilization. Results will be analyzed and submitted for publication later this year.
Martin Mayse, founder and CEO of Pleural Dynamics, said completing enrollment marks a significant milestone for the company. “We’re eagerly anticipating the outcomes data, which we believe will validate what patients and clinicians have already begun to tell us — that this device is making a meaningful difference in their quality of life,” Mayse said.
The study findings are expected to help support the U.S. market release of the ACES system later in 2025.
