Dr. Erik Hofman of the St. Antonius hospital oversaw their first trial of an innovative new flushing system, first tested at the Amsterdam UMC. This multicenter FLUID (FLUsh with Investigational Device) trial will verify the huge benefits this innovation can have in the care of post-operative heart patients.
“This is an exciting trial to be part of,”stated Dr. Hofman, when asked about St. Antonius’ involvement. “This technology promises to propel us into a new era of post-operative care and drainage to prevent complications.”
Blood-related complications following heart surgery have always been a big source of concern. An otherwise successful surgery might suddenly start to go wrong because of clotting or other complication. Adding to the concern and uncertainty is the fact that surgeons have lacked insight into how their patients are faring, post operation. This remarkable wound drainage technology promises to change all this.
Invented by Dr. David Koolbergen, a prominent heart surgeon at the Amsterdam Medical Centre (AMC), the investigational drainage device has been developed by Demcon and Haermonics, the start-up co-founded by Dr. Koolbergen to bring this promising solution to market. The device continuously flushes the space around the heart following surgery, while simultaneously providing medical staff with real-time data about the patient’s status.
St. Antonius is now the second of four medical centres that will be trialing the investigational device, after a successful trial start at the AMC. The St. Antonius hospital is especially notable in that it is one of the largest heart centers in the Netherlands. The expectation is that the trial will confirm the technology’s proven ability to drastically reduce or prevent such complications as atrial fibrillation and the need for blood transfusions or re-operations and, of course, a reduction in the number of days required in IC. In addition to validating expectations, data from the FLUID trial will be used in part for CE and FDA approval.
For many, the faster this technology can be made available the better. A big reduction in complications translates into big savings: by one estimate, €3.2 billion annually. Even more significant are the estimated savings in lives – each year, tens of thousands of heart-surgery patients die unnecessarily from post-surgery blood-related complications.
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.
Thanks to Haermonics, heart surgery patients are a step closer to avoiding all too prevalent post-operative complications. Haermonics, a clinical stage medical device company focused on preventing post-operative complications after open heart surgery, and Amsterdam UMC (study sponsor) have successfully included the first patient in their FLUID multicenter clinical trial. Dr. D.R. Koolbergen, congenital cardiothoracic surgeon at Amsterdam UMC and inventor of the technology, piloted the recently developed investigational device with their first patient.
The FLUID (FLUsh with Investigational Device) trial tests out an innovative postoperative technology to improve wound drainage. Already proven in a prototype setting with over 340 patients, it is now automated to ensure scalability. The technology comprehends novel wound drainage to ensure patient safety and produces new patient monitoring data to give clinicians extra clinical information about the patient’s status.
“Blood loss is the silent cause of many complications after heart surgery,” says Wouter Markus, CEO of Haermonics, “Every year, 30,000 patients worldwide die from post-operative heart surgery complications that are preventable, costing $22B annually and untold misery. This trial brings us a big step closer to changing that story. After all, the smartest way to solve a problem is to prevent it.”
The multi-center FLUID trial aims to strengthen the evidence that this innovative wound drainage system is able to reduce excessive bleeding and other postoperative complications such as re-operations. Amsterdam UMC, LUMC and the St Antonius hospital in Nieuwegein are participating. Two earlier randomized trials have proven that the technology reduces post-operative blood loss by more than 50% and prevent occlusion of the outflow drainage tubes, which is the cause of complications in17% of all open-heart surgeries.
Haermonics’ achievement is built on more than a decade of scientific and clinical research conducted at the Amsterdam UMC hospital and Haermonics’ research facilities. Haermonics’ partner Demcon developed the investigational device, which is used during the first hours after surgery. The device controls a flushing process by which the internal wound is cleaned from blood and clots, ensuring the patency of the wound drainage system. It is the accumulation of blood and clots in the space around the heart that is responsible for many, sometimes lifethreatening complications.