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HAERMONICS today announced the Company has received Breakthrough Device Designation status from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for their HAERMONICS LAEBROIDES® flushing system for cardiothoracic surgery with the intention to reduce post-operative bleeding and post-operative complications.
The HAERMONICS LAEBROIDES® System cleans the peri-surgical space (pericardial, pleural and mediastinal) after cardio-thoracic surgery, thereby reducing post-operative bleeding and postoperative complications related to bleeding or coagulation. The LAEBROIDES® System works by reducing clogging of the chest tubes, thereby maintaining patency of the drainage and preventing subsequent accumulation of blood and clots in the pericardial space. The system monitors the post-operative blood loss and intra-cavital pressure. This continuous monitoring of critical patient parameters is currently not provided by any available system. By providing this information and insight, the HAERMONICS LAEBROIDES® promises peace of mind to cardiac surgeons and ICU staff alike, and safer post-operative care to patients.
“Up until now, postoperative complications and re-operations were just considered a given when patients undergo heart surgery” said Wouter Markus, Chief Executive Officer of HAERMONICS. “The LAEBROIDES® System changes that. Thanks to the FDA’s Breakthrough Device Designation, we are a step closer to making this life-changing technology available for patients requiring heart surgery.”
Breakthrough Device Designation is an FDA program designed to help patients and their physicians receive timely access to technologies that have the potential to provide more effective treatment or diagnosis for debilitating conditions of great unmet need, such as postoperative complications due to excessive bleeding and clotting. As part of this designation, the FDA will provide HAERMONICS with priority review and the opportunity to interact with FDA’s experts throughout the premarket review phase as the technology moves toward eventual commercialization. HAERMONICS considers the breakthrough designation of their LAEBROIDES® device a recognition for the available proof of efficacy and the clinical need to provide patients with improved care by expediting the implementation of the LAEBROIDES® flushing device and disposables.
HAERMONICS has proven efficacy in 2 randomized clinical trials and is now building the final device while the technology is being validated in a multicenter trial in the Netherlands.
