Valiant Captivia Stent Graft with the Captivia Delivery System for Thoracic Endovascular Aortic Repair (TEVAR)

  

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Valiant Thoracic stent graft with the Captivia delivery system wrapped around the covered stent graft

Overview

Proven design and performance offer a broad set of options to treat a wide range of patient anatomies. With more than 100,000 patients treated worldwide, the Valiant Captivia stent graft system is designed to treat all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), type B aortic dissection (TBAD), intramural hematoma (IMH), penetrating atherosclerotic (PAU), and blunt thoracic aortic injury (BTAI).

Indications

The Valiant thoracic stent graft with the Captivia delivery system is indicated for treatment of diseases of the descending thoracic aorta, including but not limited to, aneurysms and dissections. The Valiant thoracic stent graft is indicated for exclusion of the aneurysm, the false lumen or site of rupture, and restoration of blood flow through the stent graft lumen. The device is intended for use in patients who are candidates for conventional surgical repair, and in patients who are not candidates for conventional surgical repair due to pre-existing risk factors.

Product Details

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.

Optimised Access

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

 

Optimal Seal

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

Precise Deployment

  • 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.

Ease of Access

  • Crossing profile is similar to or lower than other thoracic stent grafts.
  • Hydrophilic coating facilitates stent graft delivery.
  • Three-step deployment with tip capture release provides precise stent graft placement.

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. Optimal seal: 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.
Close-up images of the Valiant thoracic stent graft design highlighting key product features

Clinician Experiences

Clinician Experiences with Valiant Captivia Video - (03:06)

Watch this video to hear leading clinicians discuss why they choose the Valiant Captivia stent graft system for their patients.
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Dr. Jean Panneton Conformability Video - (03:07)

Watch this video and hear Dr. Panneton discuss how Valiant Captivia is highly flexible and conformable due to its sinusoidal shape, super‑elastic nitinol springs, and lack of a longitudinal bar.
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Dr. Frank Arko Accuracy Video - (02:34)

See how the three-step Captivia delivery system enables simple graft adjustment and precise placement within the thoracic aorta.
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Dr. Hitoshi Matsuda Dissection Video - (02:10)

Watch this video and hear Dr. Matsuda review a type B aortic dissection case he treated with TEVAR, which provides a minimally invasive alternative to open surgical repair.
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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.

Valiant Captivia Deployment Video

View an animation of the three-step deployment process of the Valiant thoracic stent graft with the Captivia delivery system.

Easy Three-step Deployment Process

For further information about the deployment steps, refer to the Instructions for Use.

Step 1

Slow, controlled deployment for precise placement

Initiate deployment, hold delivery system with one hand on front grip, use other hand to rotate the slider counterclockwise

Step 2

Quick deployment option, if desired

Continue withdrawing graft until distal spring is fully deployed; for rapid deployment, hold trigger and pull slider back

Step 3

Tip capture release

To release proximal bare stent, rotate tip capture release handle counterclockwise then pull tip capture release handle back

Manuals and Technical Guides

Instructions for Use

Find this technical manual in the product labeling supplied with each device.

Model Specifications

pdf#page=1 Valiant Stent Graft Sizing Sheet  (.pdf#page=1)

Use this tool to plan case specifics such as sizing and placement.

pdf#page=2 Ordering Information (.pdf#page=2)

See model specs including stent graft lengths, diameters, tapers, and crossing profiles.

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.
Heli-FX EndoAnchor implant on a white background

Heli-FX EndoAnchor Implant

Aortic Neck Diameter
(Proximal or Distal)
≤ 60°                    > 60° and ≤ 75° > 75° and < 90°
≤ 29 mm 4 4 4
30–32 mm 4 4 5
33–36 mm 4 5 7
37–40 mm 5 6 8
> 40 mm 5 7 9

Sizing of the anatomy and EndoAnchor implant decisions are the responsibility of the physician.

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