American medical device firm Pleural Dynamics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new ACES Automatic Continuous Effusion Shunt System.
The ACES system is intended to provide continuous symptom alleviation and doesn’t require costly drainage canisters, longer hospital stay, or a catheter external to the chest.
The Minnesota-based Pleural Dynamics is said to be the first and only company to provide a fully implantable automatic effusion shunt that is driven by normal breathing.
Dartmouth-Hitchcock Medical Center pulmonary and critical care medicine chief David Feller-Kopman said: “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.”
Pleurodesis, which is the current standard of care, is frequently painful and necessitates an extended hospital stay, said Pleural Dynamics. The one-piece, completely implanted ACES system from the company can be implanted during a brief hospital stay and is said to address these shortcomings.
Pleural Dynamics’ technology utilises natural breathing movements to automatically transfer pleural effusion fluid from the chest to the abdomen, where it can be reabsorbed by the body. This eliminates the necessity for an external catheter and the frequent need for drainage, thereby ensuring continuous symptom relief.
The company will now start real-world clinical use of the ACES system with a few hospitals and health systems.
It also anticipates that the technology will significantly enhance the quality of life for people with intractable pleural effusion.
