Pleural Dynamics Treats First Patient in “The ACES Study for Aseptic Pleural Effusions,” a Post Market Clinical Study for its Novel ACES™ Automatic Continuous Effusion Shunt System
26 Junio 2024 - 9:00AM
Business Wire
Pleural Dynamics brings to patients the first and only fully
implantable automatic effusion shunt with no external catheters or
expensive drainage canisters to patients, providing an innovative
new option for pleural effusion care.
Pleural Dynamics, a medical device company that is building
solutions for chronic, recurrent fluid collections in the body,
today announced that the Company has initiated “The ACES Study for
Aseptic Pleural Effusions,” a post-market clinical study for the
ACES™ Automatic Continuous Effusion Shunt System with the first
device implantation performed at the University of North Carolina
at Chapel Hill by study site leader Jason Akulian, MD, MPH, MBA
Associate Professor of Medicine and Section Chief of Interventional
Pulmonology and Pulmonary Oncology at University of North Carolina
Division of Pulmonary Diseases and Critical Care Medicine and
Benjamin E. Haithcock, MD, Professor of Surgery and Anesthesiology,
Interim Division Chief of Cardiothoracic Surgery. Pleural Dynamics
is the first and only company to provide a fully implantable
automatic effusion shunt that is powered by normal breathing and is
designed for continuous symptom relief, and does not require an
extended hospital stay, a catheter external to the chest, or
expensive drainage canisters.
The current standard of care, pleurodesis, is often painful,
requires an extended hospital stay, and is often unsuccessful
requiring additional procedures to manage the effusion1. While an
alternate approach—indwelling pleural catheters—exists, it requires
that the patient have a portion of the catheter to be external to
the chest and requires frequent drainage into proprietary external
canisters to relieve symptoms. Pleural Dynamics’ patented ACES™
System addresses these shortcomings2 with its one-piece, fully
implanted system that can be placed during a short hospital stay.
This technology is designed to use normal breathing motion to
automatically pump pleural effusion fluid out of the chest to the
abdomen for reabsorption by the body eliminating the need for an
external catheter and frequent drainage, providing ongoing symptom
relief.
“Providing our patients with a solution that improves their
quality of life and lessens the burden of maintaining an implanted
medical device for their chronic medical condition has the
potential to really change the way we manage pleural disease,” said
Dr. Akulian. Added Fabien Maldonado, the study Principal
Investigator, and Professor of Medicine and Thoracic Surgery at
Vanderbilt University, “Through this study, we hope to demonstrate
the clinical benefits of the ACES™ System, which may eliminate the
need for pleurodesis with its associated long and expensive
hospital stays and pleural catheters with their external drains,
their frequent and burdensome drainage procedures as well as the
costly drainage systems, and in so doing improve patient outcomes
overall.”
In this prospective, single arm, multi-center registry,
approximately 25 patients at several US centers who have
experienced recurrent symptomatic pleural effusion will be
enrolled. All patients in the study will have the change in pleural
effusion volume measured to demonstrate ACES System function and
assessments of shortness of breath, quality of life and healthcare
utilization to demonstrate impact on patients’ health and
well-being.
“This study seeks to build on the compelling performance of the
ACES™ Automatic Continuous Effusion Shunt System we’ve observed in
the lab, by providing real-world outcomes for this patient
population,” said Martin Mayse, MD, Pleural Dynamics founder and
CEO. “We believe making this unique solution available is an
exciting proposition for physicians and patients alike.”
The ACES™ System received FDA 510(k) clearance in August 2023,
and the initiation of this study marks the first stage of full
market release of this system which will play a vital role in
improving the lives of patients with intractable pleural
effusion.
About Pleural Dynamics
Pleural Dynamics is 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.
2Heffner 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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Martin Mayse, MD CEO, Pleural Dynamics
mmayse@PleuralDynamics.com