Latest news with #ClearFlow
Yahoo
21-05-2025
- Health
- Yahoo
Chest tube clearance system demonstrates value in cardiac surgery study
A trial of ClearFlow's PleuraFlow Active Clearance Technology (ACT) has demonstrated the value in adding the system into Enhanced Recovery After Cardiac Surgery (ERAS) cardiac programme protocols. Securing US Food and Drug Administration (FDA) clearance in 2010, PleuraFlow ensures that chest tubes are unobstructed in adult cardiac surgery patients and that blood or fluid has been effectively evacuated from surgical sites post-operatively. The system also functions to reduce retained blood, a known contributor to postoperative complications, including pleural effusions and post-operative atrial fibrillation (POAF). Conducted at Franciscan Health in Indianapolis, US, ClearFlow's prospective observational study included 1,334 adult cardiac surgery patients. The 650-patient control group received standard drainage while the 684-patient intervention group received PleuraFlow. In the intervention group, respective reductions of 41%, 30%, and 64% were achieved in the incidence of retained blood syndrome (RBS), median ICU hours, and ICU readmissions. PleuraFlow also demonstrated a 17% reduction in POAF and a 23% decrease in total chest drainage. The study findings were published in the journal Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery. Dr Marc Gerdisch, chief of cardiovascular and thoracic surgery, co-director of the Heart Valve Center at Franciscan Health and principal investigator of the study, commented: 'We studied the clinical outcomes and financial implications of PleuraFlow chest drains when added to our established ERAS cardiac program protocols.' Research suggests that ERAS protocols result in faster hospital discharge and potentially reductions in surgical complications. The protocol aims to improve recovery and reduce complications following surgery by taking steps to optimise a patient's health before, during, and after the procedure. Dr Gerdisch continued: 'The unequivocal positive results have led to significantly fewer complications and hospital days. More recently, we have leveraged our confidence that the chest is well drained to achieve a median time to extubation of zero hours. Perhaps most importantly, the bedside nurse can ensure the chest drain is patent.' In 2016, ClearFlow received an expanded indication clearance from the FDA for PleuraFlow's use in the treatment of paediatric cardiothoracic surgery patients. PleuraFlow ACT remains the only FDA-cleared device indicated to prevent or minimise retained blood in patients recovering from heart surgery. "Chest tube clearance system demonstrates value in cardiac surgery study" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Business Wire
20-05-2025
- Health
- Business Wire
Clinical Trial Results Show Active Chest Tube Clearance as Part of an ERAS Program Significantly Improves Outcomes in Cardiac Surgery
IRVINE, Calif.--(BUSINESS WIRE)--ClearFlow, Inc., a medical device company based in Irvine, California, announced positive results from a clinical trial published in the peer-reviewed journal Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery. The study, conducted by cardiac surgeons at Franciscan Health Indianapolis, is detailed in the article, ' Active Chest Tube Clearance Added to an Enhanced Recovery After Cardiac Surgery (ERAS) Program Improves Outcomes and Reduces Resource Utilization. ' The prospective trial evaluated ClearFlow's PleuraFlow Active Clearance Technology (ACT) System, which significantly reduced retained blood complications in heart surgery patients. The system minimized chest tube clogging, lowered the incidence of retained blood syndrome (RBS) and postoperative atrial fibrillation (POAF), as well as reduced median ICU hours during recovery. The PleuraFlow System, used at the bedside in the ICU, enables clinicians to maintain chest tube patency without compromising the sterile field. By ensuring effective evacuation of blood and fluid from the surgical site postoperatively, PleuraFlow reduces retained blood, a known contributor to complications such as POAF, pleural effusions, and pericardial effusions. Conducted from January 2020 to August 2023 at Franciscan Health Indianapolis, this pragmatic, prospective observational study included 1,334 adult cardiac surgery patients. The control group (650 patients) received standard drainage, while the intervention group (684 patients) received PleuraFlow's Active Tube Clearance. Key findings demonstrated for the patients receiving Active Tube Clearance include: 41% reduction in RBS (8.2% vs. 4.8%, p=0.014) 17% decrease in POAF (33.8% vs. 28.1%, p=0.049) 30% reduction in median ICU hours (51.6 vs. 36.3 hours, p<0.001) 64% reduction in ICU readmissions (3.2% vs. 1.17%, p=0.013) 23% decrease in total chest drainage (p<0.001), enabling earlier chest tube removal and faster recovery Principal investigator Marc Gerdisch, MD, Chief of Cardiovascular and Thoracic Surgery and Co-Director of the Heart Valve Center at Franciscan Health, stated, 'We studied the clinical outcomes and financial implications of PleuraFlow chest drains when added to our established ERAS Cardiac program protocols. The unequivocal positive results have led to significantly fewer complications, and hospital days. More recently, we have leveraged our confidence the chest is well drained to achieve a median time to extubation of zero hours. Perhaps most importantly, the bedside nurse is able to ensure the chest drain is patent.' Louis Perrault, MD, PhD, a study coauthor and cardiac surgeon at the Montreal Heart Institute, added, 'Conventional chest tubes are prone to clogging, which can hinder recovery. This study, alongside prior research, strongly supports incorporating PleuraFlow's active clearance into ERAS Cardiac Surgery programs to reduce RBS, POAF, and ICU time.' 'This study strengthens the evidence for PleuraFlow's role in improving patient outcomes,' said Hannah Beathard, CEO of ClearFlow. 'By maintaining chest tube patency, PleuraFlow reduces retained blood and related complications, aligning with the ERAS Cardiac Society's Class I, Level B-NR recommendation for active chest tube maintenance as a critical component of optimal cardiac surgery recovery.' About ClearFlow, Inc. ClearFlow, Inc. is an Irvine, 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 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.
Yahoo
20-05-2025
- Health
- Yahoo
Clinical Trial Results Show Active Chest Tube Clearance as Part of an ERAS Program Significantly Improves Outcomes in Cardiac Surgery
Significant Reductions in Chest Tube Clogging, Complications, and Resource Use Demonstrated in Prospective Study IRVINE, Calif., May 20, 2025--(BUSINESS WIRE)--ClearFlow, Inc., a medical device company based in Irvine, California, announced positive results from a clinical trial published in the peer-reviewed journal Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery. The study, conducted by cardiac surgeons at Franciscan Health Indianapolis, is detailed in the article, "Active Chest Tube Clearance Added to an Enhanced Recovery After Cardiac Surgery (ERAS) Program Improves Outcomes and Reduces Resource Utilization." The prospective trial evaluated ClearFlow's PleuraFlow Active Clearance Technology (ACT) System, which significantly reduced retained blood complications in heart surgery patients. The system minimized chest tube clogging, lowered the incidence of retained blood syndrome (RBS) and postoperative atrial fibrillation (POAF), as well as reduced median ICU hours during recovery. The PleuraFlow System, used at the bedside in the ICU, enables clinicians to maintain chest tube patency without compromising the sterile field. By ensuring effective evacuation of blood and fluid from the surgical site postoperatively, PleuraFlow reduces retained blood, a known contributor to complications such as POAF, pleural effusions, and pericardial effusions. Conducted from January 2020 to August 2023 at Franciscan Health Indianapolis, this pragmatic, prospective observational study included 1,334 adult cardiac surgery patients. The control group (650 patients) received standard drainage, while the intervention group (684 patients) received PleuraFlow's Active Tube Clearance. Key findings demonstrated for the patients receiving Active Tube Clearance include: 41% reduction in RBS (8.2% vs. 4.8%, p=0.014) 17% decrease in POAF (33.8% vs. 28.1%, p=0.049) 30% reduction in median ICU hours (51.6 vs. 36.3 hours, p<0.001) 64% reduction in ICU readmissions (3.2% vs. 1.17%, p=0.013) 23% decrease in total chest drainage (p<0.001), enabling earlier chest tube removal and faster recovery Principal investigator Marc Gerdisch, MD, Chief of Cardiovascular and Thoracic Surgery and Co-Director of the Heart Valve Center at Franciscan Health, stated, "We studied the clinical outcomes and financial implications of PleuraFlow chest drains when added to our established ERAS Cardiac program protocols. The unequivocal positive results have led to significantly fewer complications, and hospital days. More recently, we have leveraged our confidence the chest is well drained to achieve a median time to extubation of zero hours. Perhaps most importantly, the bedside nurse is able to ensure the chest drain is patent." Louis Perrault, MD, PhD, a study coauthor and cardiac surgeon at the Montreal Heart Institute, added, "Conventional chest tubes are prone to clogging, which can hinder recovery. This study, alongside prior research, strongly supports incorporating PleuraFlow's active clearance into ERAS Cardiac Surgery programs to reduce RBS, POAF, and ICU time." "This study strengthens the evidence for PleuraFlow's role in improving patient outcomes," said Hannah Beathard, CEO of ClearFlow. "By maintaining chest tube patency, PleuraFlow reduces retained blood and related complications, aligning with the ERAS Cardiac Society's Class I, Level B-NR recommendation for active chest tube maintenance as a critical component of optimal cardiac surgery recovery." About ClearFlow, Inc. ClearFlow, Inc. is an Irvine, 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 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 and Active Clearance Technology are registered trademarks of ClearFlow, Inc. View source version on Contacts Media Contact:Paul Williamspaul@ (310) 569-0023 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
