PleuraFlow Relieves Life-Threatening Pericardial Tamponade by Active Clearance of Chest Tubes after Heart Surgery

ANAHEIM, Calif.–(BUSINESS WIRE)–Cardiac Surgeons at the Montreal Heart Institute have published a report
featured in this month’s Annals of Thoracic Surgery detailing how
active clearance of chest tubes in the ICU non surgically treated a
life-threatening episode of pericardial tamponade in a patient
recovering from heart surgery (Annals of Thoracic Surgery, 101:
1159-1163, 2016). Affiliated with Université de Montréal in Quebec, the
Montreal Heart Institute is an ultra-specialized hospital center
dedicated to care, research, teaching, prevention, rehabilitation and
the assessment of new technologies in cardiology.

All patients recovering from heart surgery require chest tubes to
evacuate shed blood around the heart and lungs in the initial hours in
the ICU after surgery. A common issue for patients and their clinicians
is chest tube clogging, known to occur in over one-third of heart
surgery patients, and usually invisibly to doctors and nurses. When
clogging occurs, 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, known as Retained Blood Syndrome
(RBS). Re-interventions like this affect almost one in five cardiac
surgery patients. One such manifestation of Retained Blood Syndrome is
cardiac tamponade; a condition where external compression of the heart
by blood causes shock, which can be life threatening and requires an
emergency return to the operating room to remedy the situation. Cardiac
tamponade can develop rapidly, and if not treated by evacuation of the
blood, can be fatal.

In this report, the ICU clinicians used the PleuraFlow®
Active Clearance Technology® System to quickly re-establish
chest tube patency and provide relief for a patient who developed
tamponade. The PleuraFlow System was designed by ClearFlow Inc., a
medical device company based in Anaheim, California.

“This published case illustrates just how quickly tamponade can develop
early during recovery, and how important it is to be able to quickly
re-establish chest tube patency and maintain maximum blood evacuation
capacity in the ICU,” said Ed Boyle, MD, a cardiothoracic surgeon and
Co-Founder & Chairman of ClearFlow, Inc.

This comes on the heels of a newly published study in the March, 2016 Journal
of Thoracic and Cardiovascular Surgery
by independent investigators
in Germany, which affirmed a reduction in RBS interventions required
after surgery from 20% to 11% (43% reduction) in all cardiac surgery
patients when PleuraFlow was used, as well as a reduction in
post-operative atrial fibrillation (POAF) from 30% to 20% (a 33%
reduction) in propensity matched patients. (Journal
of Thoracic Cardiovascular Surgery
2016 Mar;151(3):832-838)

“This peer reviewed report again shows how keeping chest tubes free of
clot in early recovery after cardiac surgery not only reduces
complications and costs, but also can save lives,” said Paul Molloy,
Chief Executive Officer of ClearFlow.

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