Study Begins for Pleural Dynamics’ Continuous Effusion Shunt System

Pleural Dynamics has initiated its post-market clinical study for the ACES Automatic Continuous Effusion Shunt System, implanting the first device at the University of North Carolina at Chapel Hill.

“This study seeks to build on the compelling performance of the ACES Automatic Continuous Effusion Shunt System we’ve observed in the lab, by providing real-world outcomes for this patient population,” Pleural Dynamics Founder/CEO Martin Mayse, M.D., said. “We believe making this solution available is an exciting proposition for physicians and patients alike.”

Participating in the first Effusion Shunt System implant procedure was study site leader Jason Akulian, M.D., associate professor of Medicine and section chief of Interventional Pulmonology and Pulmonary Oncology at the University of North Carolina’s Division of Pulmonary Diseases and Critical Care Medicine; and Benjamin E. Haithcock, M.D., professor of Surgery and Anesthesiology, interim Division Chief of Cardiothoracic Surgery.

Pleural Dynamics claims to be the first and only company to provide a fully implantable automatic effusion shunt that is powered by normal breathing, is designed for continuous symptom relief, and does not require an extended hospital stay, a catheter external to the chest, or expensive drainage canisters.

The current standard of care, pleurodesis, is often painful, requires an extended hospital stay, and is often unsuccessful requiring additional procedures to manage the effusion.¹ While an alternate approach—indwelling pleural catheters—exists, it requires a portion of the catheter to be outside the chest and necessitates frequent drainage into proprietary external canisters to relieve symptoms. Pleural Dynamics’ patented ACES System addresses these shortcomings² with its one-piece, fully implanted system that can be placed during a short hospital stay. This technology is designed to use normal breathing motion to automatically pump pleural effusion fluid out of the chest to the abdomen for reabsorption by the body eliminating the need for an external catheter and frequent drainage, providing ongoing symptom relief.

“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,” Akulian stated.

Administrators of the prospective, single arm, multi-center registry (The ACES Study for Aseptic Pleural Effusions), will enroll approximately 25 patients at several U.S. centers who have experienced recurrent symptomatic pleural effusion. All study participants will have the change in pleural effusion volume measured to demonstrate ACES System function and assessments of shortness of breath, quality of life and healthcare utilization to demonstrate impact on patients’ health and well-being.

“Through this study, we hope to demonstrate the clinical benefits of the ACES System, which may eliminate the need for pleurodesis with its associated long and expensive hospital stays and pleural catheters with their external drains, their frequent and burdensome drainage procedures as well as the costly drainage systems, and in so doing improve patient outcomes overall,” added Fabien Maldonado, study principal investigator and professor of Medicine and Thoracic Surgery at Vanderbilt University. 

Pleural Dynamics is a Minnesota-based medical device company, founded in 2020 by pulmonologist Dr. Martin Mayse, and medtech veteran John Streeter. Frustrated with the current 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.

References
¹ Thomas R, Fysh ETH, Smith NA, Lee P, Kwan BCH, Yap E, Horwood FC, Piccolo F, Lam DCL, Garske LA, Shrestha R, Kosky C, Read CA, Murray K, Lee YCG. Effect of an Indwelling Pleural Catheter vs Talc Pleurodesis on Hospitalization Days in Patients With Malignant Pleural Effusion: The AMPLE Randomized Clinical Trial. JAMA. 2017 Nov 21;318(19):1903-1912.
² Heffner MD, John E. Management of Malignant Pleural Effusions. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. (Accessed on June 18, 2024)