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Pleural Dynamics Receives FDA 510(k) Clearance for its Novel ACES™ Automatic Continuous Effusion Shunt System

2023-10-19

Pleural Dynamics is the first and only company with a fully implantable automatic effusion shunt with no external catheters or expensive drainage canisters, providing an innovative new option for pleural effusion care. WAYZATA, Minn.--(BUSINESS WIRE)-- Pleural Dynamics, a medical device company that is building solutions for chronic, recurrent fluid collections in the body, today announced that the Company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ACES™ Automatic Continuous Effusion Shunt System. Pleural Dynamics is the first and only company to provide a fully implantable automatic effusion shunt that is powered by normal breathing and is designed for continuous symptom relief, and does not require an extended hospital stay, a catheter external to the chest, or expensive drainage canisters. “ACES focuses on patient-centered outcomes, potentially eliminating the need for a long hospital stay and chronic drainage at home. This is a potentially perfect solution,” said David Feller-Kopman, M.D., Chief, Pulmonary and Critical Care Medicine Dartmouth-Hitchcock Medical Center. Added Kevin Henseler, M.D., Interventional Radiologist, Midwest Radiology, “The procedure is straightforward and easy to perform.” The current standard of care, pleurodesis, is often painful and relies on an extended hospital stay, and while an alternate approach—indwelling pleural catheters—exists, it still requires that the patient have a portion of the tube external to the chest that requires frequent drainage into external canisters to relieve symptoms. Pleural Dynamics’ patented ACES™ System addresses these shortcomings1 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. With this FDA 510(k) clearance, Pleural Dynamics will begin real-world clinical use of the ACES™ System with select hospitals and health systems. Pleural Dynamics’ latest technology will play a vital role in improving the lives of patients with intractable pleural effusion. About Pleural Dynamics Pleural Dynamics is 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. For more information, visit and connect on LinkedIn at . References 1Heffner MD, John E. Management of Malignant Pleural Effusions. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. . (Accessed on September 29, 2023)

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机构

Pleural Dynamics, Inc.