Anaheim, CA – September 27, 2017—ClearFlow Inc., a medical device company
based in Anaheim, California, has announced the publication of significantly
positive results in a study evaluating the company’s PleuraFlow® Active Clearance
Technology® System.
Data from a peer-reviewed clinical study indicating a marked reduction in
Postoperative Atrial Fibrillation (POAF) among patients with active clearance of
chest tubes after heart surgery was published in the August edition of the Journal
of Thoracic and Cardiovascular Surgery. The study is titled “Examining the
impact of active clearance of chest drainage catheters on postoperative atrial
fibrillation” and was written by Samuel St-Onge, MD, Walid B Ali, MD, Ismail
Bouhout, MD, Denis Bouchard, MD, Yoan Lamarche, MD, Louis P Perrault, MD
and Philippe Demers, MD (http://www.jtcvsonline.org/article/S0022-5223(17)30609-8/abstract).
All patients having heart surgery are required to have drainage catheters to remove
shed blood from around the heart and lungs in the early hours of recovery
following surgery. In recent years, clinical evidence has shown that these drainage
catheters have a high failure rate due to clogging, potentially leading to retained
blood that can slow recovery, contribute to postoperative complications and
increase total cost of care. ClearFlow developed the world’s first Active Clearance
Technology® that allows care providers to prevent chest tube clogging during early
recovery of heart surgery patients. This innovative technology was developed by
surgeons seeking a solution to an unmet need for their patients and is now being
utilized in a number of leading centers of excellence around the world.
In this newly published study by independent investigators from the Montreal
Heart Institute in Montreal, Canada, a statistically significant reduction in
Postoperative Atrial Fibrillation (POAF) from 35% to 23% (a 34% reduction) was
documented among patients treated with the PleuraFlow System. In addition,
results demonstrated a trend toward shorter postoperative length of stay in the
hospital among patients treated with the PleuraFlow System’s chest drainage
protocol.
In an accompanying editorial by the same authors from the Montreal Heart
Institute, titled “Posterior pericardial drainage: Could improving chest tube patency
provide the same benefits?” (http://www.jtcvsonline.org/article/S0022-
5223(17)30609-8/abstract), the authors discussed the link between retained blood
in the pericardium and the development of POAF, and the role that active
clearance of chest tubes can play in reducing this problem.
In this editorial, Dr. St-Onge and his colleagues refer to a recently published metaanalysis
of 19 randomized, controlled trials by Gozdek et al.,
(http://www.jtcvsonline.org/article/S0022-5223(16)31682-8/pdf ). The authors
assessed whether efforts to reduce pooling of blood around the heart with posterior
pericardial drainage after cardiac procedures among 3,425 patients might be
valuable to patients’ recovery. St-Onge stated, “…it clearly establishes the
evidence that keeping the blood away from the pericardial space where it can
promote effusions and supraventricular tachyarrhythmias is important to outcomes
but also shows that conventional chest drainage does not get the job done.”
“This latest study provides an additional layer of peer-reviewed, published
evidence that retained blood plays an important role in the development of POAF,
said Paul Molloy, CEO of ClearFlow, “and that by reducing retained blood by
preventing chest tube occlusion, POAF can therefore be reduced with a medical
device. This kind of real world data is particularly helpful for hospitals looking to
reduce costs and complications as hospitals move to comply with MACRA value
healthcare regulations and provide better quality healthcare at lower costs.”
“POAF is a common complication that prolongs hospitalization and contributes to
readmissions in nearly 1 in 3 patients after heart surgery,” said Edward Boyle, MD,
Co-Founder and Chairman of ClearFlow. “Currently there are no preventative
drug regimens that can reliably prevent POAF in large cross-sections of patients,
and there is no other device technology that can make such a meaningful reduction
in this common complication by simply addressing a known shortcoming of
commonly used chest drainage catheters.”
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 2017 Global Frost & Sullivan Award for New Product Innovation, 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, Active Clearance Technology, and FlowGlide are registered
trademarks of ClearFlow, Inc.
Media Contact:
Paul Williams
310/569-0023
paul@medialinecommunications.com