Terumo

The next advancement

in flow diversion technology

The FRED X device builds upon the same precise, predictable placement and immediate opening of the previous generation FRED™ device2, now with X Technology. X Technology is designed to:

  • Reduce Material Thrombogenicity1
  • Maintain Natural Vessel Healing1
Hubspot_V2

1

Precise, Predictable Placement and Immediate Opening

2

Only FDA PMA approved system with 0.021" delivery options

3

X Technology Surface Modification

Introducing x technology

Proprietary, Nanoscale Surface Modification

Water layer_with labels (1)

X Technology creates an optimized, protective hydration layer around FRED X that is designed to reduce platelet adhesion while allowing for endothelial cell attachment and growth1-5.

X Technology is covalently bonded to the FRED X implant for a permanent chemical change to the device surface2.

Why X-1 Technology?

Before selecting X Technology, MicroVention’s engineers conducted extensive in-vitro testing of FRED devices treated with various surface modifications2.

FRED X Brochure v19 (3)_Page_2_Edit_v2

Chevron_Teal FRED X is Designed to Reduce Material Thrombogenicity

Scanning electron microscope (SEM) imaging from in-vitro testing demonstrates a reduction of thrombus formation on the FRED X device compared to a bare device, and comparable thrombus reduction to Pipeline™ Shield1,*.

FRED X Assets-01

Bare Device
FRED X Assets-02

Pipeline Shield
FRED X Assets-03

FRED X

SEM images from in-vitro testing at MicroVention
*Pipeline™ Flex Embolization Device with Shield Technology™ is a product of Medtronic

Chevron_Teal FRED X is Designed to Maintain Natural Vessel Healing

In-vitro cell culture testing demonstrated that X Technology maintained comparable endothelial cell growth to that of a bare device, while other polymers showed little signs of cell growth2,5.

Bare_Untreated_Device-1

Bare Device
Phosphorylcholine_Treated_Device

Phosphorylcholine
FRED_X_(PEMA)_Device

FRED X

Cell culture images from in-vitro testing at MicroVention.

Chevron_Teal FRED X Provides Easier Tracking

Graph-1

Results of in-vitro trackability testing performed at MicroVention.

Videos

Dr. Tjoumakaris presents FRED X device experience and 6-mo FU, SNIS 2022

Introducing the X Technology Surface Modification

FRED X Flow Diverter Interview with Dr. Zhang, SNIS 2022
Watch more FRED X videos

FRED X Publications

JNIS thumbnail
JNIS Publication
The FRESH Study thumbnail-1
FRESH Study Publication

Contact your local MicroVention representative for more information.

Indications, Safety & Warnings
  1. Data is derived from in-vitro testing and may not be representative of clinical performance.
  2. Data on file at MicroVention.
  3. Tanaka M et al. Design of biocompatible and biodegradable polymers based on intermediate water concept. Polymer Journal. 2015;47:114-121.
  4. Tanaka M et al. Blood compatible aspects of poly(2-methoxyethylacrylate) (PMEA) – relationship between protein adsorption and platelet adhesion on PMEA surface. Biomaterials. 2000;21:1471-1481.
  5. Sato, C., Aoki, M. & Tanaka, M. Blood-compatible poly(2-methoxyethyl acrylate) for the adhesion and proliferation of endothelialand smooth muscle cells. Colloids and Surfaces B: Biointerfaces145, 586–596 (2016).

FRED™ X System Product Indications, USA:
The Flow Re-Direction Endoluminal Device (FRED) System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment of adult patients (22 years of age or older) with wide‐necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm. 

Contraindications:
Patients with known hypersensitivity to nickel-titanium 
Patients in whom angiography demonstrated inappropriate anatomy that does not permit passage or deployment of the FRED X System 
Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs are contraindicated

For complete indications, contraindications, potential complications, warnings, precautions, and instructions, see instructions for use (IFU provided in the device). 

For Professional Use Only
RX Only: Federal (FDA) law restricts this device to sale by or on the order of a physician. 

FRED and MICROVENTION are registered trademarks of MicroVention, Inc. in the United States and other jurisdictions. Stylized X is a trademark of MicroVention, Inc. Third party brands are trademarks of their respective owners.

©2022 MicroVention, Inc. MM1279 US 11/22

MicroVention Worldwide Innovation Center

35 Enterprise
Aliso Viejo, CA 92656 USA
Phone: 1 (714) 247-8000
Customer Service: 1 (800) 990-8368
microvention.com