In collaboration with the company Pleural Dynamics, UNC School of Medicine researchers led by Jason Akulian, MD, associate professor in the Department of Medicine, are the first to use a fully implantable automatic effusion shunt with no external catheters or expensive drainage canisters to provide an innovative new option for patients who struggle with chronic fluid collection.
As part of a post-market clinical study, researchers at the University of North Carolina at Chapel Hill have implanted the ACES™ Automatic Continuous Effusion Shunt System into its first patient. This innovative solution addresses chronic fluid collection due to pleural effusion.
The FDA-approved device, created by Pleural Dynamics, is a fully implantable automatic effusion shunt powered by normal breathing and designed for continuous symptom relief. The intervention does not require an extended hospital stay, a catheter external to the chest, or expensive drainage canisters, unlike traditional treatments such as pleurodesis and indwelling pleural catheters.
“Providing our patients with a solution that improves their quality of life and lessens the burden of maintaining an implanted medical device for their chronic medical condition has the potential to really change the way we manage pleural disease,” said Jason Akulian, MD, MPH, MBA, UNC site leader, associate professor of medicine in the UNC Division of Pulmonary Diseases and Critical Care Medicine.
In this prospective, single arm, multi-center registry, approximately 25 patients who have experienced recurrent symptomatic pleural effusion will be enrolled at several US medical centers.
The study will measure changes in pleural effusion volume, assess shortness of breath, quality of life, and healthcare utilization, demonstrating the ACES System’s function and impact.
The ACES™ System received FDA 510(k) clearance in October 2023. The initiation of this study at the University of North Carolina marks the first stage of full market release of the system which is expected to significantly improve the lives of patients with intractable pleural effusion.
Benjamin E. Haithcock, MD, professor of surgery and anesthesiology at UNC and interim division chief of UNC Cardiothoracic Surgery, assisted in the implementation of the ACES™ System.
Media contact: Kelsey Haywood, Research Program Director, UNC Division of Pulmonary and Critical Care Medicine
Written by Morgan Duerden, Communication Specialist, UNC Department of Medicine