{"id":55204,"date":"2023-03-27T14:04:18","date_gmt":"2023-03-27T12:04:18","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/saranas-reaches-midpoint-for-enrollment-in-clinical-trial-assessing-the-utility-of-early-bleed-detection-in-patients-undergoing-mechanical-circulatory-support\/"},"modified":"2023-03-27T14:04:18","modified_gmt":"2023-03-27T12:04:18","slug":"saranas-reaches-midpoint-for-enrollment-in-clinical-trial-assessing-the-utility-of-early-bleed-detection-in-patients-undergoing-mechanical-circulatory-support","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/saranas-reaches-midpoint-for-enrollment-in-clinical-trial-assessing-the-utility-of-early-bleed-detection-in-patients-undergoing-mechanical-circulatory-support\/","title":{"rendered":"Saranas Reaches Midpoint for Enrollment in Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support"},"content":{"rendered":"
\n

\nSAFE-MCS Examines the Impact of the Early Bird\u00ae<\/sup> Bleed Monitoring System on Reducing Bleeding Complications in Patients Undergoing High Risk PCI with Mechanical Circulatory Support<\/i>\n<\/p>\n

HOUSTON–(BUSINESS WIRE)–Saranas, Inc. announced today that it has reached the midpoint for enrollment in SAFE-MCS, a multi-center, single arm, open-label clinical trial evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the Early Bird\u00ae<\/sup> Bleed Monitoring System. The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system. It was launched in 2019 following a De Novo classification by the U.S. Food and Drug Administration. The device monitors and detects endovascular bleed complications through a novel application of bioimpedance sensors.\n<\/p>\n

<\/a><\/p>\n

\n\u201cAs the use of MCS increases worldwide, the SAFE-MCS study will bring important insight on what the true rate of bleeding events are during those procedures, and how to improve safety outcomes of patients undergoing complex and high-risk interventions,\u201d stated Dr. Philippe Genereux, interventional cardiologist and Director of the Structural Heart Disease Program at Morristown Medical Center and co-principal investigator of SAFE-MCS.\n<\/p>\n

\nSAFE-MCS will enroll up to 265 patients across multiple centers in the United States. The primary endpoint of the study is incidence of access-site related BARC (Bleeding Academic Research Consortium) type III or V bleeding. Patients undergoing complex high-risk PCI with mechanical circulatory support (MCS) via Impella and transfemoral arterial approach are enrolled as study participants. The Early Bird Bleed Monitoring System is used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.\n<\/p>\n

\n\u201cTimely identification of bleeding events is crucial in preventing adverse events that can have serious consequences for patients. The data from SAFE-MCS will provide meaningful guidance on how real-time monitoring can improve clinical outcomes through a proactive approach to managing bleeding risk,\u201d said Dr. Babar Basir, Director of Acute Mechanical Circulatory Support, at Henry Ford Health System and co-principal investigator of SAFE-MCS.\n<\/p>\n

\nSaranas is partnering with the Cardiovascular Research Foundation (CRF) Clinical Trials Center to assess cost savings associated with the Early Bird in the SAFE-MCS trial. \u201cAs health systems are highly sensitive to the burden of incremental costs from procedural complications, it is more important than ever to quantify the economic value of innovative technologies like early bleed detection,\u201d said Dr. David Cohen, Director of Clinical and Outcomes Research at CRF.\n<\/p>\n

\n\u201cWe are pleased to announce that we have reached the midpoint for enrollment in the SAFE-MCS trial,\u201d said Saranas President and CEO Mike MacKinnon. \u201cThis is an important milestone in our efforts to continue building clinical evidence to support the utility of the Early Bird device. Saranas is committed to establishing a new standard of care for bleed detection during and after endovascular procedures to improve patient outcomes and reduce healthcare costs.\u201d\n<\/p>\n

\nApproximately one in every five patients will experience a bleeding complication during large-bore endovascular procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), and percutaneous MCS. The average cost of a single bleeding complication incident across these large-bore procedures is approximately $18,000 with an estimated $729 million cost on the healthcare system1<\/sup>. The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.\n<\/p>\n

\nTo learn more about SAFE-MCS, please visit the study record on clinicaltrials.gov.\n<\/p>\n

\nAbout the Early Bird Bleed Monitoring System<\/b>\n<\/p>\n

\nThe Early Bird Bleed Monitoring System includes a bleed detection array with integrated electrodes in a fully functional vascular access sheath. It is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), mechanical circulatory support (MCS) device placement, or other complex endovascular interventions, where the femoral artery or vein is used to obtain vascular access. Visual and audible indicators on the Early Bird notify the clinician of the onset and progression of bleeding events. In the FIH clinical study, bleed detection with the Early Bird was compared with a CT scan, the gold standard, and level of agreement was nearly perfect with 100% sensitivity2<\/sup>.\n<\/p>\n

\nAbout Saranas, Inc.<\/b>\n<\/p>\n

\nSaranas, Inc. is a privately held Houston-based medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications. The company\u2019s patented Early Bird Bleed Monitoring System for vascular access procedures enables physicians to mitigate downstream consequences by addressing bleeding complications immediately, improving patient outcomes, and lowering healthcare costs. For more information, please visit www.saranas.com<\/a>.\n<\/p>\n\n\n\n
\n

\n1.\n<\/p>\n<\/td>\n

<\/td>\n\n

\nRedfors B et al. Mortality, length of stay, and cost implications of procedural bleeding after percutaneous interventions using large-bore catheters. JAMA Cardiol. 2017 Jul 1;2(7):798-802.\n<\/p>\n<\/td>\n<\/tr>\n

\n

\n2.\n<\/p>\n<\/td>\n

<\/td>\n\n

\nGenereux P et al. First-in-Human Study of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events. J Invasive Cardiol. 2020 Jul;32(7):255-261. Epub 2020 Jun 8.\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\n\u00a0\n<\/p>\n

Contacts<\/b> <\/p>\n

\nKristen Lomas
\n
klomas@saranas.com<\/a>
310-529-5431\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

SAFE-MCS Examines the Impact of the Early Bird\u00ae Bleed Monitoring System on Reducing Bleeding Complications in Patients Undergoing High Risk PCI with Mechanical Circulatory Support HOUSTON–(BUSINESS WIRE)–Saranas, Inc. announced today that it has reached the midpoint for enrollment in SAFE-MCS, a multi-center, single arm, open-label clinical trial evaluating the safety of complex high-risk percutaneous coronary … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-55204","6":"format-standard","7":"category-industry"},"yoast_head":"\nSaranas Reaches Midpoint for Enrollment in Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/saranas-reaches-midpoint-for-enrollment-in-clinical-trial-assessing-the-utility-of-early-bleed-detection-in-patients-undergoing-mechanical-circulatory-support\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Saranas Reaches Midpoint for Enrollment in Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"SAFE-MCS Examines the Impact of the Early Bird\u00ae Bleed Monitoring System on Reducing Bleeding Complications in Patients Undergoing High Risk PCI with Mechanical Circulatory Support HOUSTON–(BUSINESS WIRE)–Saranas, Inc. announced today that it has reached the midpoint for enrollment in SAFE-MCS, a multi-center, single arm, open-label clinical trial evaluating the safety of complex high-risk percutaneous coronary ... 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