Pleural Dynamics today announced positive results from a prospective, multicenter study evaluating its ACES (automatic continuous effusion shunt) device.
Plymouth, Minnesota-based Pleural Dynamics developed ACES to treat chronic pleural effusions. It describes it as the first and only fully implantable automatic effusion shunt that uses the motion of normal breathing to remove fluid from the chest. It offers continuous symptom relief without requiring an extended hospital stay, a catheter external to the chest or expensive drainage canisters.
The device addresses the shortcomings of the current standards for care in treating pleural effusion, the company says. Its one-piece, fully implanted system offers a minimally invasive option for a short hospital stay.
Findings from a prospective, multi-center study presented at the CHEST 2025 Annual Meeting demonstrated that the device resulted in a 53% mean reduction in pleural effusion volume at 30 days. Investigators also reported no adverse events related to fluid diversion to the abdomen.
The ACES study evaluated the device’s safety, feasibility and efficacy in patients with non-infectious recurrent pleural effusions. It enrolled 25 patients across leading U.S. centers. Investigators observed a median hospital discharge time of one day, highlighting the potential for streamlined recovery and reduced healthcare burden.
Pleural Dynamics reported that the study met its primary endpoint with the pleural effusion volume reduction. ACES delivered a 96% rate of implantation success. Additionally, 80% of patients required no additional drainage out to 60 days. Patient-reported outcomes also demonstrated trends toward reduced shortness of breath and improved quality of life. Additionally, 84% of patients said they would recommend ACES to others.
The study milestone adds to a recent Medicare win for ACES and completed enrollment in a post-market clinical study.
“We are excited to have this data reinforcing the strong safety profile and clinical effectiveness of the ACES device, demonstrating clinically meaningful and statistically significant reductions in pleural effusion volume and resulting in lower rates of repeat drainage procedures for patients,” said Dr. Martin Mayse, CEO of Pleural Dynamics. “With this supporting evidence and the recently issued reimbursement code from CMS, we are well positioned to bring this transformative therapy to patients suffering from recurrent effusions who are in need of a better treatment option, all across the U.S.”
