Maquet Medical Systems USA announced today an exclusive US distribution agreement with ClearFlow, Inc. for its innovative PleuraFlow® Active Clearance Technology® (ACT™) System. The PleuraFlow System enables caregivers to actively keep chest drainage tubes clear of clot in the early hours after heart surgery. Maquet's sales representatives in the United States will begin selling PleuraFlow ACT during the first quarter of 2015.
PleuraFlow ACT received 510(k) regulatory clearance from the U.S. Food and Drug Administration in December 2010. In October 2014, ClearFlow announced positive results from the Prevention of Retained Blood Outcomes Using Active Clearance Technology trial, (PRO-ACT), a clinical study evaluating the use of PleuraFlow® Active Clearance Technology® System.
"Too many patients are experiencing complications and additional procedures as a result of the common occurrence of chest tube occlusion," said ClearFlow President & CEO, Paul Molloy. "Meanwhile, inconsistent protocols used for wound drainage post-cardiac surgery create costs that hospitals and patients have to bear. It is our mission to reduce the incidence of chest tube occlusion by ensuring the availability of PleuraFlow ACT, and we believe that Maquet is the ideal distribution partner."
"We are very pleased to form this alliance with such a renowned and well-respected medical device company," said ClearFlow Co-Founder Ed Boyle, MD. "Maquet is the world market leader in thoracic drainage for patients recovering from heart and lung surgery. We share Maquet's goals of improving patient outcomes and reducing hospital costs with highly innovative novel medical device technologies, and look forward to a mutually beneficial relationship."
Raoul Quintero, President and CEO North America, said, "Maquet's commitment to being a trusted partner to our customers means seeking out innovation to provide superior products and for better patient outcomes. PleuraFlow ACT is unique as it is the only FDA 510(k) cleared device of its kind to effectively and reproducibly clear obstructing material from chest tubes without compromising the sterile field. We're excited to be the only company to offer PleuraFlow ACT to our US customers and their patients."
Maquet, a trusted partner for hospitals and physicians for more than 175 years, is a global leader in medical systems. The company offers innovative therapy solutions and infrastructure capabilities for high-acuity areas within the hospital — including the operating room (OR), hybrid OR/cath lab, and intensive care unit (ICU) — as well as intra- and inter-hospital patient transport. Additionally, Maquet develops intelligent and sustainable room concepts that exceed the expectations of modern hospitals, working in close cooperation with customers, production engineers and architects to integrate high quality products and services.
Headquartered in Rastatt, Germany, Maquet is the largest subsidiary of the publicly listed Getinge Group AB of Sweden. Maquet generated about 1.54 billion Euros in 2013, representing more than half of the Getinge Group's annual revenue of 2.9 billion Euros. Maquet has 6,550 employees and provides 40 international sales and service organizations, as well as a network of more than 300 sales partners. For more information, please visit www.Maquet.com.
ClearFlow, Inc. is an Anaheim, CA based medical device company developing proprietary active blood and fluid evacuation systems to speed recovery, reduce complications and lower healthcare costs in patients recovering from surgery. The company has been awarded several prestigious awards, including the European Association of Cardiothoracic Surgeons (EACTS) 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 (ICI) for Best Start-up Innovation. ClearFlow – Flow Better. The company is currently enrolling programs in its ACT Registry.
Source : http://www.prnewswire.com