Mermaid Medical’s Angel® Catheter Receives CE Mark for Pulmonary Embolism Protection
In a significant move for critical care medicine, Mermaid Medical Group® announced on March 31, 2026, that the Angel® Catheter has officially received CE marking. This certification confirms the device complies with the European Union’s health, safety and environmental protection requirements, clearing the way for its use in European markets.
The Angel® Catheter is a specialized medical device designed to prevent pulmonary embolisms (PE) in critically ill patients. By combining a filter with a central venous catheter, it addresses a critical and often untreated window of risk for patients in intensive care settings.
What is the Angel® Catheter?
The Angel® Catheter is an inferior vena cava (IVC) filter that is permanently attached to a triple lumen central venous catheter. Unlike traditional IVC filters, this design allows the device to serve two purposes: providing prophylactic PE protection and granting access to the central venous system for standard clinical indications.
It is the first and only IVC filter to receive FDA clearance for a prophylactic use indication. This means it’s designed to prevent a pulmonary embolism before one occurs, rather than just treating a known condition.
Key Clinical Advantages
The design of the Angel® Catheter introduces several “game-changing” benefits for physicians and patients:
- Guaranteed Retrieval: One of the most significant challenges with traditional IVC filters is the difficulty of removal. The Angel® Catheter guarantees retrieval, a promise that distinguishes it from other filters on the market.
- Bedside Placement: The device can be placed at the patient’s bedside. This eliminates the need to transport critically ill patients to an endovascular suite for the initial procedure.
- Simplified Positioning: After placement, clinicians can confirm the filter’s position using an abdominal radiograph (KUB). If the filter isn’t perfectly placed, it can be repositioned as needed.
- Controlled Removal: Although placement is simple, optimal removal is performed in an endovascular suite under fluoroscopy. Physicians use a cavogram to identify any potential thrombus before removing the device.
Technical Specifications
For medical professionals, the Angel® Catheter offers specific technical capabilities to ensure integration with existing critical care workflows:
| Feature | Specification |
|---|---|
| Filter Size | 30 x 50 mm |
| Catheter Profile | 9F, 30cm usable length |
| Power Injection | Distal and Proximal ports |
| MR Compatibility | MR conditional (1.5 and 3 Tesla) |
| Guidewire Compatibility | 0.035’’ |
Recognized Innovation
The device’s unique approach to PE protection has gained industry recognition, including winning the Premier Breakthrough Innovation Award in 2023. By providing immediate protection during a high-risk window for critically ill patients, it offers a level of security that traditional filters cannot match.
Key Takeaways
- CE Mark: Received March 31, 2026, allowing EU distribution.
- Dual Purpose: Acts as both an IVC filter and a triple lumen central venous catheter.
- Prophylactic Use: Specifically cleared to prevent PE in critical care patients.
- Ease of Use: Allows for bedside placement and guaranteed retrieval.
The arrival of the Angel® Catheter in the European market represents a shift toward more flexible, lower-risk interventions for pulmonary embolism prevention in the ICU. As critical care continues to evolve, the ability to provide guaranteed retrieval and bedside placement will likely improve patient outcomes and reduce the complications associated with permanent IVC filters.
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