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Zenith Dissection Endovascular System

FDA PMA

Class III (US FDA PMA)

PMA P180001

by William Cook Europe ApS

Identity

Trade Name
Zenith Dissection Endovascular System FDA PMA
Generic Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT FDA PMA

Identifiers

PMA Number
P180001 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 Zenith Dissection Endovascular System is an endovascular graft and stent system indicated for the treatment of Type B aortic dissection. It is designed to seal entry tears and exclude aneurysms associated with chronic dissections, with the Zenith TX2 Dissection Endovascular Graft with Pro-Form sealing the entry tear and the Zenith Dissection Endovascular Stent providing distal support to delaminated non-aneurysmal aortic segments.

The system is supplied sterile and intended for single-use in endovascular repair procedures. It requires adequate iliac/femoral access and is indicated for patients with suitable vascular anatomy, including specific fixation site dimensions: graft fixation sites require at least 20 mm length and 20–38 mm diameter, while stent implantation requires a true lumen diameter of 20–38 mm. The device is authorized under FDA PMA P180001.

Frequently asked questions

What is the Zenith Dissection Endovascular System used for?

The Zenith Dissection Endovascular System is used for the endovascular treatment of patients with Type B aortic dissection. It seals the entry tear(s) and excludes aneurysms associated with chronic dissections using the Zenith TX2 Dissection Endovascular Graft with Pro-Form, while the Zenith Dissection Endovascular Stent provides distal support to delaminated segments of non-aneurysmal aorta with dissection distal to the graft.

What are the size requirements for using the Zenith Dissection Endovascular System?

For the Zenith TX2 Dissection Endovascular Graft with Pro-Form, fixation sites must have a length of at least 20 mm and a diameter between 20 mm and 38 mm (outer-wall to outer-wall). For the Zenith Dissection Endovascular Stent, the intended implant site must have a true lumen diameter of no greater than 38 mm and no less than 20 mm (total aortic diameter). Adequate iliac/femoral access is also required for introduction systems.

Is the Zenith Dissection Endovascular System reusable or single-use?

The Zenith Dissection Endovascular System is supplied sterile and intended for single-use only. Reuse is not indicated in the provided specifications and would compromise sterility and device integrity.

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

United States Active

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Manufacturer

Manufacturer
William Cook Europe ApS

Sources (1)

  • FDA PMA P180001 24 fields · synced Sep 18, 2026