Endologix Powerlink IntuiTrak Transport System Manual

The Powerlink system and IntuiTrak delivery system is a percutaneously implanted stent graft system for the treatment of abdominal aortic aneurysms (AAA). The system consists of two parts: an implantable stent graft and a single-use delivery catheter. The pre-assembled stent graft is inserted via the femoral artery or iliac artery by a guidewire through a percutaneous approach and expanded to its rated diameter upon deployment and retraction of the delivery system. On deployment and expansion, the stent graft is intended to create a closed graft seal at both the proximal and distal ends of the aneurysm.


Endologix Powerlink IntuiTrak Transport System Manual - cover page
Brand
PowerLink
Category
Other device
Document type
User Manual
Language
Chinese
Pages
37
File format
PDF
File size
1 MB
Updated
30 September, 2023
MD5 checksum
2EF3A25CE1A899313C1F030AC9A43DB1

About this manual

The Endologix Powerlink system, together with the IntuiTrak transport system, is a single‑use, endovascular device for treating abdominal aortic aneurysms (AAA). It consists of a self‑expanding ePTFE‑covered stent graft and optional extension components that are delivered via disposable catheters.

The manual provides device description, indications, contraindications, warnings, implantation procedure, MRI compatibility, adverse event reporting, device tracking, and return instructions. It is intended for trained physicians and their interventional teams. This manual is written in Chinese.

What's inside

  • Device Introduction
  • Indications
  • Contraindications
  • Warnings and Precautions
  • Patient Selection, Treatment and Follow‑up
  • Implant Procedure
  • MRI Safety and Compatibility
  • Adverse Events
  • Device Tracking Information
  • Returns

Specifications

Leg (branch) diameter13–16 mm
Delivery catheter outer diameter17 Fr or 19 Fr
Fast delivery system outer diameter21 Fr
Compatible guidewire size0.035 inch

Frequently asked questions

What is the intended use of the Powerlink system?

The Powerlink system and its extension components are intended for endovascular treatment of abdominal aortic aneurysm (AAA) in patients suitable for such repair.

Can the Powerlink system be reused or re‑sterilized?

No. The system is designed for single‑patient, single‑use only and must not be reprocessed or re‑sterilized.

What are the contraindications for using the Powerlink system?

It should not be used in patients who are sensitive or allergic to the device materials.

Is the Powerlink stent MRI compatible?

The stent can be used under conditional MRI conditions, such as 1.5 T or 3.0 T static fields with specific SAR limits.

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