Pleural Dynamics, a company specializing in medical devices aimed at addressing chronic and recurring bodily fluid accumulations, has announced its receipt of FDA 510(k) clearance for the innovative ACES™ Automatic Continuous Effusion Shunt System. This revolutionary system stands out as the only fully implantable automatic effusion shunt powered by natural respiration, ensuring ongoing symptom relief without the need for extended hospital stays, external chest catheters, or expensive drainage apparatus. ACES™ System focuses on enhancing patient outcomes, potentially eliminating the requirement for prolonged hospitalization and at-home drainage.

In contrast, the current standard of care, pleurodesis, often involves pain and extended hospital stays. While an alternative approach, indwelling pleural catheters, is available, it still necessitates an external portion of the catheter and regular drainage into external containers to alleviate symptoms. Pleural Dynamics' patented ACES™ System is poised to address these issues with its all-in-one implantable solution, which can be inserted during a brief hospital stay.

This innovative technology utilizes natural breathing motion to automatically redirect pleural effusion fluid from the chest to the abdomen for reabsorption by the body, thereby eliminating the need for an external catheter and frequent drainage, and providing lasting symptom relief. Having secured FDA 510(k) clearance, Pleural Dynamics is now ready to initiate real-world clinical use of the ACES™ System in partnership with select hospitals and healthcare systems, potentially transforming the landscape of patient care.

Source: businesswire.com