Zilver PTX Drug-Eluting Peripheral Stent
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT FDA PMA
- Generic Name
- Stent, superficial femoral artery, drug-eluting FDA PMA
Identifiers
- PMA Number
- P100022 FDA PMA
- FDA Product Code
- NIU FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Zilver PTX Drug-Eluting Peripheral Stent is a drug-eluting stent designed for improving luminal diameter in the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries. It is classified as a stent for the superficial femoral artery and is intended for use in vessels with reference diameters ranging from 4 mm to 9 mm and lesion lengths up to 140 mm per limb or 280 mm per patient.
This device is supplied in a sterile, single-use configuration and is approved for use under an FDA Premarket Approval (PMA). It is intended for use in clinical settings such as interventional radiology or vascular surgery, where precise placement within specified vessel dimensions is required. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.
Frequently asked questions
What types of blood vessels is the Zilver PTX Drug-Eluting Peripheral Stent designed to treat, and what are the key size limitations for use?
The Zilver PTX is specifically designed for improving blood flow in the above-the-knee femoropopliteal arteries, treating both new (de novo) and recurring (restenotic) blockages. It is intended for vessels with reference diameters between 4 mm and 9 mm and can address lesion lengths up to 140 mm per limb or 280 mm total per patient. This makes it suitable for longer or more complex arterial segments in this region.
Is the Zilver PTX Drug-Eluting Peripheral Stent intended for reuse, or is it meant to be used only once per patient?
The Zilver PTX is supplied in a sterile, single-use configuration, meaning each device is designed for one procedure per patient. Reuse is not recommended or supported, as it could compromise sterility and device integrity. Proper sterile handling and storage protocols must be followed to ensure safety and effectiveness.
What clinical settings or specialties would typically use the Zilver PTX, and why is precise vessel sizing important?
This stent is intended for use in interventional radiology or vascular surgery settings, where precise catheter-based techniques are employed. The device is engineered for vessels with specific diameter and length requirements (4–9 mm, up to 140 mm per limb), so accurate pre-procedure imaging and sizing are critical to ensure proper deployment and optimal outcomes. Misalignment or incorrect sizing could lead to suboptimal stent expansion or coverage.
How should the Zilver PTX be stored, and what precautions should be taken to maintain its sterility?
As a sterile, single-use device, the Zilver PTX must be stored in its original packaging under controlled conditions to preserve sterility. Storage should comply with standard sterile medical device protocols, typically in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediately before use, and any damaged or compromised packaging should be discarded to prevent contamination.
What regulatory pathway was followed for the approval of the Zilver PTX, and what does that mean for its use in clinical practice?
The Zilver PTX received FDA Premarket Approval (PMA) under PMA number P100022, indicating a rigorous review process to ensure safety and effectiveness for its intended use. This approval means the device has been evaluated for treating de novo or restenotic lesions in the above-the-knee femoropopliteal arteries within the specified vessel size and length parameters. Clinicians should confirm compliance with the approved labeling and procedural guidelines when using it.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100022 | Class III | Active |
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Manufacturer
- Manufacturer
- Cook Ireland, Ltd.
Sources (1)
- FDA PMA P100022 24 fields · synced Sep 18, 2026