TRELLIS-8 Peripheral Infusion System
FDA 510(k)Class II (US FDA 510(k))
by Covidien
Identifiers
- 510(k) Number
- K130904 FDA 510(k)
- FDA Product Code
- QEY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Trellis-8 Peripheral Infusion System is a mechanical thrombectomy catheter designed for pharmacomechanical thrombectomy. It features two occluding balloons with drug infusion ports between them, enabling localized delivery and mechanical dispersion of thrombolytic agents to dissolve clots in peripheral veins. This device is intended for use in isolated, single-session procedures to treat deep vein thrombosis (DVT).
The system is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K130904) as a Class II medical device (regulation number 870.5150). It is used in interventional radiology or cardiology settings for acute DVT treatment, reducing the need for prolonged catheter-directed thrombolysis. The device’s design allows for rapid thrombus lysis and aspiration within 15 to 20 minutes, minimizing procedural time and patient exposure. Storage and handling follow standard sterile catheter protocols.
Frequently asked questions
What is the Trellis-8 Peripheral Infusion System used for?
The Trellis-8 is designed specifically for pharmacomechanical thrombectomy to treat deep vein thrombosis (DVT) in peripheral veins. It uses two occluding balloons with drug infusion ports to deliver thrombolytic agents directly to the clot, enabling both mechanical dispersion and localized chemical dissolution. This approach is intended for isolated, single-session procedures to restore venous flow efficiently.
How is the Trellis-8 supplied and what does sterility mean for its use?
The Trellis-8 is supplied as a sterile, single-use device, meaning each unit is packaged to prevent contamination and intended for one-time clinical use only. Sterility ensures patient safety by eliminating the risk of infection from microbial contamination, which is critical in interventional procedures like thrombectomy. After use, the device must be discarded, and sterile barriers must be maintained during handling.
Is the Trellis-8 reusable, or is it meant for one-time procedures?
The Trellis-8 is explicitly designed as a single-use device. Reusing it would compromise sterility and potentially introduce infection risks, which is why it is not intended for reuse. Single-use devices are engineered for one procedure per sterile package, aligning with best practices for patient safety and regulatory standards.
What are the key procedural advantages of using the Trellis-8 compared to traditional methods?
The Trellis-8 reduces procedural time significantly by combining mechanical clot fragmentation with localized thrombolytic infusion, achieving thrombus lysis and aspiration in approximately 15–20 minutes. This minimizes patient exposure to prolonged catheter-directed thrombolysis, which can carry higher risks of bleeding or complications. The system is optimized for acute DVT treatment in interventional radiology or cardiology settings.
How should the Trellis-8 be stored before use, and what precautions are necessary?
The Trellis-8 must be stored according to standard sterile catheter protocols to preserve its integrity and sterility. This includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, verify the sterile seal is intact, and handle the device using aseptic techniques to prevent contamination. Improper storage could compromise the device’s performance or safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: The Trellis System for DVT Treatment - Endovascular Today, PDF The Trellis System for DVT Treatment, PDF One-Step Treatment of DVT With the Trellis-8 Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130904 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien
Sources (1)
- FDA 510(k) K130904 24 fields · synced Oct 1, 2026