Pleural Dynamics Announces Completion of Enrollment of 'The ACES Study for Aseptic Pleural Effusions,' a Post Market Study Evaluating the Novel ACES Automatic Continuous Effusion Shunt System
'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.' - Martin Mayse, Founder and CEO of Pleural Dynamics.
The current standards of care for recurrent pleural effusion (PE) have several significant shortcomings for patients. One standard approach for treating recurrent PE's is pleurodesis, which is painful, requires an extended hospital stay, and is often unsuccessful requiring additional procedures (1). A common alternate approach—indwelling pleural catheters—requires a portion of the catheter to be external to the chest and needs frequent drainage into expensive external canisters to relieve symptoms. Pleural Dynamics' patented ACES™ System addresses these shortcomings (2) with its one-piece, fully implanted system that is placed with a minimally invasive procedure during a short hospital stay. The device uses normal breathing motion to automatically pump pleural effusion fluid from the chest into the abdomen for reabsorption by the body, eliminating the need for an external catheter and frequent drainage. It is designed to relieve the shortness of breath associated with PE's and improve the quality of life for patients.
'We're thrilled to have participated in this study of the ACES device for patients suffering from recurrent pleural effusion, and to have been the center to enroll the last patient and bring this study to a close,' said Mark Block, M.D., Chief of Thoracic Surgery at Memorial Healthcare System. 'This marks a major step toward understanding how this device can improve not only clinical outcomes but also the day-to-day quality of life for these patients struggling with other comorbidities like cancer. We look forward to seeing the data and are excited by the potential ACES holds for transforming care for this often-overlooked condition.'
In this prospective, multi-center, single-arm study, 25 patients experiencing recurrent symptomatic pleural effusions at four U.S. centers received the ACES device. All study patients are being monitored for changes in their pleural effusion volume to demonstrate ACES System function. Other assessments evaluate shortness of breath, quality of life, and healthcare utilization to demonstrate the impact on patients' health and well-being. Study results will be summarized and submitted for publication later this year.
'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.'
The ACES System received FDA 510(k) clearance in August 2023, and the results of this study will support the market release of the device in the United States later this year.
About Pleural Dynamics
Pleural Dynamics is a 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 https://www.pleuraldynamics.com/ and connect on LinkedIn at https://www.linkedin.com/company/pleural-dynamics-inc/.
References
1 Thomas R, Fysh ETH, Smith NA, Lee P, Kwan BCH, Yap E, Horwood FC, Piccolo F, Lam DCL, Garske LA, Shrestha R, Kosky C, Read CA, Murray K, Lee YCG. Effect of an Indwelling Pleural Catheter vs Talc Pleurodesis on Hospitalization Days in Patients With Malignant Pleural Effusion: The AMPLE Randomized Clinical Trial. JAMA. 2017 Nov 21;318(19):1903-1912.
2 Heffner MD, John E. Management of Malignant Pleural Effusions. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. (Accessed on June 18, 2024)
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