Pleural Dynamics announced today that it completed enrollment in a post-market clinical study for its ACES system.
Minneapolis-based Pleural Dynamics designed the ACES (automatic continuous effusion shunt) system as the first and only fully implantable automatic effusion shunt that uses the motion of normal breathing to remove fluid from the chest. It offers continuous symptom relief without requiring an extended hospital stay, a catheter external to the chest or expensive drainage canisters.
The ACES system received FDA 510(k) clearance in August 2023. Pleural Dynamics expects the results of its study to support its planned market release in the U.S later this year. Its single-arm study evaluates 25 patients across four U.S. centers.
According to the company, the current standards of care for recurrent pleural effusion (PE) have significant shortcomings. One approach — pleurodesis — generally proves painful and requires an extended hospital stay and often additional procedures. Indwelling pleural catheters also offer an alternative, but require a portion of the catheter to be external to the chest. This requires frequent drainage into expensive canisters.
Pleural Dynamics designed ACES to address the shortcomings through a one-piece, fully implanted system placed through a minimally invasive procedure. The device uses normal breathing motion to automatically pump pleural effusion fluid from the chest into the abdomen. This enables reabsorption by the body and eliminates the need for an external catheter and frequent drainage.
The company says it relieves the shortness of breath associated with PEs and improves quality of life for patients.
“Completing enrollment in this study is a proud milestone for our team,” said Martin Mayse, founder and CEO of Pleural Dynamics. “We’re eagerly anticipating the outcomes data, which we believe will validate what patients and clinicians have already begun to tell us — that this device is making a meaningful difference in their quality of life. Hearing stories from patients who’ve experienced decreased shortness of breath and renewed ease in daily activities reinforces our mission to bring forward innovations that improve lives.”
