Cook Medical’s Zenith Dissection Endovascular Stent for Aortic Tears FDA Approved

The FDA has given approval to Cook Medical‘s Zenith Dissection Endovascular Stent for treatment of symptomatic aortic dissection distal to the left subclavian artery. It is intended to be used along with the company’s Zenith TX2 Dissection Endovascular Graft with Pro-Form Straight Component or Tapered Component

Zenith Dissection relies on the Z-Trak Plus Introduction System for delivery and placement of the device within the aorta, which can be performed via the iliac or femoral access.

It is a flexible metal stent graft with a fabric covering and there’s an optional bare stent available as well to provide support.

Here are some of the patient requirements that have to be met for the stent to be appropriate for placement, according to the product page:

Adequate iliac/femoral access compatible with the required introduction systems; when used together with the Zenith TX2 Dissection Endovascular Graft with Pro-Form.

Radius of curvature greater than 35 mm along the entire length of aorta intended to be treated by the Zenith Dissection Endovascular Stent.

Localized angulation less than 45 degrees.

Diameter at intended implant site (measured outer wall to outer wall) of no greater than 38 mm (true lumen) and no less than 20 mm (total aortic diameter).