Valiant Thoracic Stent Graft with Captivia Delivery System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- VALIANT THORACIC STENT GRAFT SYSTEM FDA PMA
- Generic Name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT FDA PMA
Identifiers
- PMA Number
- P100040 FDA PMA
- FDA Product Code
- MIH FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Valiant Thoracic Stent Graft with Captivia Delivery System is an endovascular graft designed for the treatment of fusiform aneurysms and penetrating ulcers in the descending thoracic aorta. Classified as a System, Endovascular Graft, Aortic Aneurysm Treatment, it is intended for patients with appropriate anatomy, including compatible iliac/femoral access vessels, non-aneurysmal aortic diameters between 18–42 mm, and non-aneurysmal proximal and distal neck lengths of at least 20 mm.
This device is delivered via the Captivia system and is supplied sterile for single-use. It is regulated under FDA PMA (P100040) and falls under Class III medical device classification. Multiple sizes and reference codes are available, as listed in the registration data, ensuring compatibility with varying patient anatomies. Usage requires endovascular techniques and is performed in controlled clinical settings.
Frequently asked questions
What specific types of aortic conditions is the Valiant Thoracic Stent Graft with Captivia Delivery System designed to treat?
The Valiant Thoracic Stent Graft is specifically designed for the endovascular repair of **fusiform aneurysms** and **penetrating ulcers** in the **descending thoracic aorta**. It is not intended for all aortic conditions but is tailored for patients with compatible anatomy, including non-aneurysmal aortic diameters between **18–42 mm** and non-aneurysmal neck lengths of at least **20 mm** in both proximal and distal regions.
How is the Valiant Thoracic Stent Graft supplied, and is it reusable?
The device is supplied **sterile** and is intended for **single-use only**. It comes pre-packaged for clinical use in controlled settings, ensuring sterility and compliance with endovascular procedures. Reuse is not recommended or supported by the manufacturer.
What anatomical requirements must a patient meet to be eligible for this device?
Eligibility depends on specific anatomical criteria, including **compatible iliac/femoral access vessels** for vascular access techniques, a **non-aneurysmal aortic diameter between 18–42 mm**, and **non-aneurysmal proximal and distal neck lengths of at least 20 mm**. These requirements ensure proper placement and functionality of the stent graft.
Are there multiple sizes available for the Valiant Thoracic Stent Graft, and how do I determine the correct size for a patient?
Yes, the device is available in **multiple sizes** to accommodate varying patient anatomies. The correct size is determined based on the patient’s **aortic diameter (18–42 mm)** and neck lengths, as well as the specific **reference codes** listed in the registration data. Consulting the manufacturer’s sizing guidelines or a vascular specialist is recommended to select the appropriate graft.
What regulatory pathway was followed for the approval of this device, and how is it classified?
The Valiant Thoracic Stent Graft with Captivia Delivery System was approved through the **FDA Premarket Approval (PMA) process**, specifically under **PMA number P100040**. It is classified as a **Class III medical device**, indicating it carries higher risk and requires stringent regulatory oversight due to its endovascular use in critical aortic conditions.
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 | P100040 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA PMA P100040 24 fields · synced Oct 6, 2026