Study Shows Significant Pleural Effusion Volume Reduction With ACES Device

Pleural Dynamics Inc. is sharing positive study results for its Automatic Continuous Effusion Shunt (ACES) device in managing symptomatic recurrent pleural effusions. The study showed that ACES implantation resulted in a 53% median reduction in pleural effusion volume at 30 days, with no adverse events related to fluid diversion to the abdomen reported.

The ACES study (NCT06210685) evaluated the fully internalized ACES pleuroperitoneal shunt’s safety, feasibility, and efficacy in patients with non-infectious recurrent pleural effusions. Unlike current approaches that require frequent outpatient drainage through an externalized catheter or prolonged hospitalization for invasive pleurodesis procedures, ACES automatically drains pleural fluid to the peritoneum using the patient’s natural breathing motion, thereby eliminating the need for additional hospital stays for pleural effusion management.

Twenty-five patients were enrolled in various U.S. academic centers including Johns Hopkins University, the University of North Carolina, Vanderbilt University, and Memorial Healthcare System. Median hospital discharge time was only one day, highlighting the potential for streamlined recovery and reduced healthcare burden. The study met its primary endpoint with a 53% median reduction in pleural effusion volume at 30 days (n=23, p<0.001).

“These findings support the potential of ACES as a safe and effective alternative for managing recurrent pleural effusions without repeated drainage or inpatient procedures,” said Jeffrey Thiboutot, M.D., of Johns Hopkins University. “The procedure is easy to perform and well-tolerated by patients, and we are pleased to have ACES as a new option for patients suffering from recurrent pleural effusions.” 

The ACES device had a 96% implantation success rate, with 80% of patients requiring no additional drainage out to 60 days. Additionally, patient-reported outcomes demonstrated trends toward reduced shortness of breath and improved quality of life, and when asked ,84% of patients would recommend ACES to others.

“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,” Pleural Dynamics CEO Martin Mayse, M.D., stated. “With this supporting evidence and the recently issued reimbursement code from CMS, we are well-positioned to bring this therapy to patients suffering from recurrent effusions who are in need of a better treatment option, all across the U.S.”

Pleural Dynamics is a Minnesota-based medical device company, founded in 2020 by pulmonologist Dr. Mayse and medtech veteran John Streeter. Frustrated with the costly, cumbersome, and decades-old technologies to treat debilitating pleural diseases, Pleural Dynamics seeks to revolutionize care by bringing effective treatment options to patients and providers that reduce the overall cost of care through reductions in hospital stays, decreased caretaker labor, and reduced infection rates.