Saranas Achieves De Novo FDA Clearance for Their Endovascular Monitoring System
Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird Bleed Monitoring System.
According to a recent study of over 17,000 large-bore transcatheter interventions from the National Inpatient Sample Database, one in five patients experienced a bleed complication. A 2017 report in the Journal of the American Medical Association (JAMA) reported a three times increase in mortality, two times increase in length of hospital stay and 60 percent increase in healthcare costs of procedural bleeding after percutaneous interventions using large-bore catheters.
“Gaining FDA approval for the Early Bird is a significant milestone for Saranas as it demonstrates our continued commitment to address an unmet need for real-time detection and monitoring of endovascular bleed complications,” said Saranas President and CEO Zaffer Syed. “As the first and only device on the market for early bleed detection, we have the potential to significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures.”
The Early Bird Bleed Monitoring System includes a vascular access sheath with embedded bioimpedance sensors that are designed to detect and monitor bleeding from vessel injury which may occur during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), large bore hemodynamic support device placement, or other complex cardiovascular interventions, where the femoral artery or vein is used to obtain vascular access. In an animal study to support FDA review of the device’s effectiveness, the Early Bird was able to detect internal bleeds with 100% sensitivity and 100% specificity.1
“Bleeding remains an Achilles’ heel of advancing minimally-invasive, catheter-based procedures,” said Dr. Dimitrios Karmpaliotis, Director of Chronic Total Occlusions, Complex and High Risk Angioplasty at Columbia University Medical Center. “The Early Bird will play a key role in making these procedures safer in the future by providing physicians bleed monitoring in real-time.”
“Peri-procedural bleeding associated with endovascular procedures has a significant impact on patient safety and adds incremental costs to the healthcare system with longer hospital stays and additional interventional treatment,” stated Saranas Chief Medical Officer Dr. Philippe Généreux. “I firmly believe the Early Bird Bleed Monitoring System will help protect, and in some cases, save the lives of patients undergoing an endovascular procedure by allowing physicians to detect the onset of bleeding early and take appropriate steps to address the bleed before detrimental, irreversible and life-threatening consequences occur.”
The Early Bird Bleed Monitoring System is currently being piloted in multiple centers to assess the versatility of the Early Bird to potentially increase patient safety with improved bleed status monitoring during and after endovascular access procedures. Saranas plans to commercially launch the device in select centers of excellence across the U.S.
See Press Release at the Source: FDA Grants Saranas De Novo Designation for the Early BirdTM Bleed Monitoring System | Business Wire
Press Release by Saranas
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