Valiant Thoracic Stent Graft with the Captivia Delivery System

U.S. INDICATIONS  

The Valiant™ Thoracic Stent Graft System with the Captivia™ Delivery System is intended for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having appropriate anatomy, including:

• Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;
• Nonaneurysmal aortic diameter in the range of 18 mm to 42 mm (fusiform and saccular aneurysms/penetrating ulcers), 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 mm to 44 mm (dissections); and
• Nonaneurysmal aortic proximal and distal neck lengths ≥20 mm (fusiform and saccular aneurysms/penetrating ulcers), landing zone ≥20 mm proximal to the primary entry tear (blunt traumatic aortic injuries, dissections). The proximal extent of the landing zone must not be dissected.

PRODUCT DETAILS

Features

The Valiant Captivia system is built on our 19+ years of thoracic stent graft experience. The Valiant stent graft has a unique, durable design that is flexible, conforms to individual patient anatomy, and ensures accurate placement.

Conformability

• Sinusoidal shape and placement of nitinol springs provide flexibility and conformability.
• Super-elastic nitinol springs exert active radial force to enhance seal and conformability.

Accuracy

• Tip capture provides controlled deployment and precise placement in the thoracic aorta.
• Tip capture release handle provides simple turn-and-pull motion to release proximal stents.

Optimized Access

• Crossing profile is similar to or lower than other thoracic stent grafts.
• Hydrophilic coating facilitates stent graft delivery.
• Easy three-step deployment process.

Valiant Thoracic Stent Graft with Captivia Delivery System Features

1. Proximal FreeFlo configuration: The proximal 8-peak FreeFlo configuration evenly distributes radial force over multiple apices.
2. Enhanced conformability: Absence of a longitudinal bar allows for enhanced flexibility and kink resistance.
3. Visible markers: Platinum iridium Figur8 markers provide high visibility for accurate placement.
4. Broad selection of pieces: Broad selection of proximal and distal components leads to many combinations to customize for a variety of patients.

Clinician Experiences

Controlled Deployment with Tip Capture

The Captivia delivery system allows for control and accurate placement of the stent graft at every step of deployment across a range of anatomies.

Controlled Deployment with Tip Capture

1. Deployment
2. Captured
3. Released

EASY THREE-STEP DEPLOYMENT PROCESS

Step 1
Slow, controlled deployment for precise placement.

Step 2
Quick deployment option, if desired.

Step 3
Tip capture release.

^* Data on file at Medtronic.

MODEL SPECIFICATIONS

Heli-FX Thoracic Recommended Number of EndoAnchor Implants

• The following is recommended based on internal testing.
• Additional or fewer EndoAnchor implants may be placed at physician discretion.