ClearFlow Announces Positive Randomized Controlled Trial Results and Inclusion in ERAS Guideline Recommendations

ANAHEIM, Calif.–(BUSINESS WIRE)–ClearFlow, Inc., a medical device company based in Anaheim, California,
has announced that positive clinical trial results of its PleuraFlow^®
device were presented at the American Association for Thoracic
Surgery (AATS) 99^th Annual meeting on May 4 in Toronto,
Canada. This new data stems from a trial evaluating the use of
ClearFlow’s PleuraFlow^® Active Clearance Technology^®
(ACT^®) System in heart surgery patients at the Montreal Heart
Institute.

PleuraFlow is a medical device used at the bedside in the ICU that
enables caregivers to actively maintain chest tube patency following
cardiac surgery. A patent chest tube enables evacuation of blood and
fluid from the operative site after closure of the surgical wound and
reduces retained blood. Retained blood is accepted by physicians as
contributing to many common complications after surgery, including
post-operative atrial fibrillation (POAF), pleural effusions and
pericardial effusions. This prospective randomized controlled clinical
trial, presented at AATS by Dr. Samuel St-Onge, demonstrated a
statistically significant reduction in chest tube clogging and emergency
reoperations for retained blood, and a directional reduction in POAF.

“This positive randomized clinical trial comes on the heels of five
prior studies demonstrating that active maintenance of chest tube
patency after cardiac surgery reduces complications related to retained
blood,” said Dr. Edward Boyle, a cardiothoracic surgeon, and ClearFlow
founder. “This study shows once again that the PleuraFlow system
achieves a more efficient evacuation of shed mediastinal blood, which is
critical in recovery after cardiac surgery.”

Also at this year’s AATS, an international group of leading heart
surgeons, anesthesiologists and critical care specialists known as ERAS^®Cardiac
Surgery, published the first “Guidelines
for Perioperative Care: Enhanced Recovery After Surgery Society
Recommendations.” These guidelines are published in the current
edition of JAMA Surgery. In its guidelines, ERAS Cardiac
Surgery recommends maintaining chest tube patency without breaking the
sterile field to prevent retained blood complications as a Class I,
Level B-NR classification. These recommendations were also endorsed by
the Enhanced
Recovery After Surgery (ERAS®) Society.

“ERAS’ new guidelines published in JAMA Surgery combined with successful
randomized trial results represent clear validation that active
clearance of chest tubes following heart surgery reduces clinical
complications of retained blood and reduces hospital resource
utilization and costs related to treating complications,” said Paul
Molloy, CEO of ClearFlow. “The PleuraFlow System is the only device on
the market shown to proactively prevent chest tube clogging and retained
blood during early recovery in heart surgery patients.”

The PleuraFlow^® Active Clearance Technology^®
System is approved for use in the U.S., Europe, Australia, Brazil,
Canada, Mexico and other countries in Asia and the Middle East.

About ClearFlow, Inc.

ClearFlow,
Inc. is an Anaheim, CA based medical device company that has developed a
patented active blood and fluid evacuation system to speed recovery,
reduce complications and lower healthcare costs related to medical tube
obstruction. The company has been awarded several prestigious awards,
including the European Association of Cardiothoracic Surgeons Techno-College
Innovation Award for a worldwide innovation that has the potential
to change the standard of care in heart and lung surgery, and the Innovations
in Cardiovascular Interventions Award, among others.

Contacts

Media Contact:
Paul Williams
[email protected]
(310)
569-0023