Unmet Need for Chest Tube Patency Standards an Area of Focus at Cardiovascular-Thoracic (CVT) Critical Care Conference

ClearFlow Participates in Clinical Panel Presentations and Round
Table at Conference Focused on Clinical Impact of Retained Blood

WASHINGTON–(BUSINESS WIRE)–ClearFlow Inc., a medical device company based in Anaheim, CA,
participated in a series of panel presentations related to the subject
of chest tube patency standards to prevent Retained Blood Syndrome (RBS)
following cardiothoracic surgery last Friday at the
Cardiovascular-Thoracic (CVT) Critical Care Conference in Washington DC.
Clinical cardiac surgery intensive care leaders from around the
world gathered at the conference, organized by the Foundation for the
Advancement of CardioThoracic Surgical Care (FACTS-Care) in Washington,
DC. CVT Critical Care Conference is one of the premier settings for
cardiac critical care exchange of ideas. Specialists meet at the CVT
Critical Care Conference each year to discuss the latest concepts,
technology, and protocols and formulate new approaches and clinical
practice standards for the care of patients recovering from heart
surgery in their hospitals.

Presentations given by Felix Balzer, MD of Charité University in Berlin
and Spencer Melby, MD of Washington University and Barnes Jewish
Hospital in St. Louis were followed by a panel discussion.

A common issue for these patients and their clinicians is chest tube
clogging, known to occur in over one-third of heart surgery patients.
Chest tubes are used for all patients recovering after heart surgery to
drain shed blood during early recovery. When this occurs, nearly one in
five patients can suffer from a range of complications, including the
need to perform subsequent re-operations or interventions to remove
blood, blood clots or bloody fluid from the pericardial or pleural
spaces after cardiac surgery. These complications are referred to as
Retained Blood Syndrome (RBS) and result in a longer length of stay,
higher mortality and a higher rate of readmissions.

At the 2014 CVT Critical Care Conference, results of clinical studies
demonstrating a marked reduction in interventions required for
complications for RBS with the PleuraFlow System were presented. The
results showed a statistically significant reduction of interventions
for RBS by 42% in the treatment group. In addition, the trial revealed a
statistically significant reduction of postoperative atrial fibrillation
(POAF). Patients treated with PleuraFlow System also had a statistically
significant reduction in bleeding, suggesting that the Active Clearance
Technology may help reduce the amount of bleeding after heart surgery.

The PleuraFlow System enables caregivers to actively keep chest drainage
tubes clear of clot in the early hours after heart surgery. PleuraFlow
is the first FDA cleared device indicated to maintain chest drain
patency and to reduce chest tube clogging and retained blood.

At this year’s meeting, Dr. Balzer presented data detailing the high
costs of RBS, not only in terms of the resulting complications and
delayed recovery for patients, but also the added financial burden
for hospitals and health care systems caring for them.

Chest tube clogging and RBS are suspected to contribute to the
development of Post Operative Atrial Fibrillation (POAF), one of the
most common complications in patients recovering from heart surgery. Dr.
Melby, a noted authority of atrial fibrillation, spoke about how blood
retained around the heart contributes to inflammation that contributes
to the development of POAF in patients after cardiac surgery.

“With a known failure rate of over one third of chest tubes due to
clogging, it is surprising that there are not national standards for
methods to routinely prevent this problem,” said Paul Molloy,
ClearFlow’s President & CEO, who also served as panel moderator. “With
growing research that allows us to better understand this issue, and how
preventing chest tube clogging with active clearance reduces the
complications of RBS, more standardized approaches are being developed,
adopted and shared by medical facilities and clinicians to improve
quality while reducing complications and costs. We’re proud that our
pioneering PleuraFlow technology can play a key role in these solutions.”

The PleuraFlow Active Clearance Technology System is approved for use in
the U.S., Europe, Australia, Brazil, and Canada, and has either cleared
or is pending clearance in over a dozen more countries.

About ClearFlow, Inc.

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 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.

PleuraFlow and Active Clearance Technology are registered trademarks
of ClearFlow, Inc.


for ClearFlow Inc.
Paul Williams, 310/569-0023