FDA has Granted Clearance for Pleural Dynamics' Novel ACES™ Continuous Effusion Shunt System

Pleural Dynamics, a medical device company dedicated to addressing chronic fluid accumulations in the body, has recently obtained FDA 510(k) clearance for its groundbreaking ACES™ Automatic Continuous Effusion Shunt System. This system distinguishes Pleural Dynamics as the first and only provider of a fully implantable automatic effusion shunt, powered by normal breathing, delivering continuous relief from symptoms without the need for extended hospital stays, external chest catheters, or costly drainage equipment.

The ACES™ System places a strong focus on patient-centered outcomes, potentially eliminating the requirement for extended hospitalization and ongoing home-based drainage. The procedure is straightforward and less invasive, offering a superior alternative to the current standard of care, often involving painful pleurodesis and prolonged hospitalization. Even the existing alternative, indwelling pleural catheters, necessitates a portion of the tube to be external to the chest, leading to frequent drainage into external containers for symptom relief.

Pleural Dynamics' patented ACES™ System overcomes these limitations with its one-piece, fully implanted design, allowing for the procedure to occur during a shorter hospital stay. This innovative technology harnesses the body's natural breathing motion to automatically transport pleural effusion fluid from the chest to the abdomen for reabsorption, eliminating the need for an external catheter and frequent drainage, thereby providing ongoing symptom relief. The ACES™ System is now poised to enter real-world clinical use with select hospitals and health systems, offering the potential to significantly enhance the quality of life for patients grappling with intractable pleural effusion.


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