Saranas Early Bird Bleed Monitoring System
Overview
The Saranas Early Bird Bleed Monitoring System is an intravascular bleed monitor designed for real-time detection and monitoring of internal bleeding complications during endovascular procedures. The system is utilized primarily by interventional cardiologists, cardiothoracic surgeons, and vascular surgeons in catheterization laboratories and cardiovascular intensive care units. It is indicated for use during large-bore access procedures where the femoral artery or vein is accessed, such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), and mechanical circulatory support (MCS) placement.
The system integrates into standard clinical workflows without altering existing endovascular protocols. It consists of a fully functional vascular access sheath (available in 6 Fr or 8 Fr) embedded with a bleed detection array of sensing electrodes, a dilator, and a user interface display. The device fits into the workflow by replacing a standard introducer sheath at the access site.
Notable Capabilities:
- Bioimpedance Monitoring: Continuously measures local tissue electrical resistance to detect extravascular fluid accumulation from vessel injury.
- Three-Stage Alarm System: Features a user interface with visual and audible indicators that trigger at three sequential levels of bleed progression (approximately 50 mL, 100 mL, and 200 mL of accumulated volume).
- Post-Procedure Monitoring: Capable of active monitoring during the procedure and up to 12 hours post-intervention.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Real-time detection and monitoring of vascular access site bleed complications.
- Utilizes a vascular access sheath with embedded electrodes.
- Measures changes in bioimpedance to detect extravascular fluid accumulation.
- Provides visual and audible indicators for bleed onset and progression with a 3-staged alarm system.
- Seamless integration into standard endovascular workflows.
- Available in 6 or 8 Fr sheath sizes.
- Can remain in place for sustained monitoring up to 12 hours post-procedure.
Use Cases
- Monitoring during Transcatheter Aortic Valve Replacement (TAVR) procedures.
- Bleed detection during Percutaneous Coronary Intervention (PCI).
- Surveillance during Mechanical Circulatory Support (MCS) device placement (e.g., Impella).
- Detection of bleeding complications in Endovascular Aneurysm Repair (EVAR).
- Monitoring for vascular injury in other complex endovascular interventions where the femoral artery or vein is accessed.
- Continuous bleed monitoring during and immediately after endovascular procedures.
What Physicians Need to Know
Physicians should leverage the Early Bird system for its unique ability to provide objective, real-time detection of internal bleeding at access sites, often before clinical symptoms manifest. This allows for proactive intervention and potentially reduces the severity of bleeding complications. Integrate its continuous monitoring and multi-level alarm system into post-procedural care protocols, especially for high-risk patients undergoing large-bore endovascular procedures.
The Saranas Early Bird Bleed Monitoring System is engineered to integrate smoothly into existing endovascular procedural workflows and protocols. It functions as a specialized introducer sheath with integrated bioimpedance sensors, rather than requiring complex integration with external electronic health records (EHR) or advanced imaging platforms for its core bleed detection functionality. Its integration is primarily at the point of care within the cath lab or recovery setting.
Details
| Category | Cardiology AI, Clinical Decision Support & Reference |
| Pricing | Unknown |
| Deployment | On-premise (medical device used in a clinical setting) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The Saranas Early Bird Bleed Monitoring System received De Novo classification (DEN180021) from the U.S. Food and Drug Administration (FDA) in March 2019. A 510(k) premarket notification (K230273) was granted on May 25, 2023, related to firmware changes. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Interventional Radiology, Vascular Surgery |
What the Web Says
The Saranas Early Bird Bleed Monitoring System is a novel device designed for real-time detection and monitoring of internal bleeding complications during and after endovascular procedures, particularly those involving large-bore access in the femoral artery or vein. It utilizes bioimpedance sensors embedded in a vascular access sheath to detect changes in tissue electrical resistance caused by extravascular fluid accumulation. The system provides visual and auditory alerts to clinicians, indicating the onset and progression of bleeding across three levels. Studies have shown its effectiveness in detecting bleeding before it becomes clinically evident, potentially improving patient outcomes and reducing complications.
Overall: PositiveStrengths
- Early and real-time detection of internal bleeding, often before clinical symptoms appear.
- Reduces the severity of bleeding complications and associated risks like increased mortality, longer hospital stays, and higher healthcare costs.
- Seamlessly integrates into existing endovascular procedural workflows.
- Provides actionable alerts (visual and auditory) to clinicians, allowing for timely intervention.
- Safe and effective across a variety of endovascular procedures, including TAVR and high-risk PCI.
- Does not add incremental risk as it utilizes an existing venous access sheath.
Limitations
- Not evaluated for safety and compatibility in the MR environment, making it MR Unsafe.
- Not recommended to insert more than one Early Bird device in the same vessel or adjoining vessel due to potential interaction.
- The benefit for superficial bleed events, which can be observed directly, is lower.
- Some studies are relatively small (e.g., 60 patients in initial human trials).
- Limited information available from independent tech reviewers or general consumer platforms like Reddit, G2, or Capterra, as it is a specialized medical device.
Based on reviews from: CLD (Cath Lab Digest), SCAI (Society for Cardiovascular Angiography & Interventions), MedTech Dive, Clinical Trials Arena, ScienceDaily, Deborah Heart & Lung Center, accessdata.fda.gov, Houston Chronicle, DAIC (Diagnostic and Interventional Cardiology), HMP Global Learning Network (Journal of Invasive Cardiology), PubMed, Diagnostic and Interventional Cardiology, Cambridge Consultants, Heart diseases (Cardiac Vascular Today), tctmd.com, Texas Heart Institute
Last updated: 2026-07-19
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