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Roadsaver™

Carotid Artery Stent

Description

MAKE A DIFFERENCE, RELY ON DETAILS

Dual layer design for sustained embolic protection.

Characteristics

  • ​SUSTAINED EMBOLIC PROTECTION

    ​DUAL LAYER DESIGN WITH MICRO-MESH TECHNOLOGY

    Dual Layer Design

    The innovative dual-layer micromesh is designed to contain plaque to the vessel wall and prevent plaque protrusion protecting against distal embolization.

    Micro-mesh Technology

    Roadsaver inner micromesh layer provides one of the smallest pore sizes of any carotid stent for sustained embolic protection1.

  • BRAIDED NITINOL STENT PLATFORM

    ​Designed as a closed cell stent with the flexibility of an open cell stent2.

    The innovative dual-layer micromesh is designed to contain plaque to the vessel wall and prevent plaque protrusion protecting against distal embolization. 

    • Provides excellent flexibility and vessel wall apposition2
    • Conforms to tortuous anatomy2,3
    • In-vivo self-tapering to ICA-CCA* segments2

  • ​​5 FR SHEATH-COMPATIBLE

    ​ENHANCED LESION CROSSABILITY4

    • Low 5 Fr profile, rapid exchange system for all stent sizes
    • Allows for easy stent delivery in complex anatomies5
    • Supports primary stenting when predilatation is not required4,5,6

  • ​​EASE OF OPERATION

    ​ADVANCED DELIVERY CATHETER 

    Delivery catheter with flexible distal tip

    • Enhanced trackability in challenging anatomy

    Pin and pull delivery system

    • Designed for ease of use by a single operator

    Stent placement accuracy

    • Fully repositionable with up to 50% deployment7
    • Allows the users to reposition the stent if needed7

  • ​GROWING BODY OF CLINICAL EVIDENCE

    ​Over 3,000 patients studied

Clinical evidence

The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery.
Bosiers M, Deloose K, Torsello G, Scheinert D, Lieven M, Peeters M, MD, Müller-Hülsbeck S, Sievert H, Langhoff R, Bosiers M, Setacci C EuroIntervention. 2016;12(5):e671-6.

The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery.
Bosiers M, Deloose K, Torsello G, Scheinert D, Lieven M, Peeters M, MD, Müller-Hülsbeck S, Sievert H, Langhoff R, Bosiers M, Setacci C EuroIntervention. 2016;12(5):e671-6.

The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery
Bosiers et al.

​​

See all clinical evidence

General specifications

Stent platform

ConstructionDouble layer, braided mesh
MaterialNitinol

Stent delivery system

Guidewire compatibility0.014" (0.36 mm)
Introducer sheath compatibility5 Fr (I.D. > 0.074'")
Delivery system constructionrapid exchange (RX), segment length 25 cm
Usable catheter length143 cm

Item specifications

Item
reference

Unconstrained dimensions (mm)

Implanted dimensions (mm)

Stent diameter

Micromesh layer stent length

Overall stent length

Vessel Ø 1 mm smaller
than unconstrained Ø

Vessel Ø 2 mm smaller
than unconstrained Ø

Vessel diameter

Micromesh layer length

Overall length

Vessel diameter

Micromesh layer length

Overall length

RDS-0520-143RX520254203332235
RDS-0530-143RX530374354733852
RDS-0540-143RX540474455935264
RDS-0616-143RX616225203242335
RDS-0625-143RX625335304443348
RDS-0630-143RX630405405344358
RDS-0718-143RX718256233552638
RDS-0725-143RX725356304753652
RDS-0730-143RX730406405354460
RDS-0820-143RX820257253662740
RDS-0825-143RX825357304963854
RDS-0830-143RX830407405564561
RDS-0840-143RX840477506766075
RDS-0920-143RX920338304573348
RDS-0930-143RX930408405574560
RDS-1020-143RX1020359304583550
RDS-1030-143RX10304394055845

60

Enlarge table

 

*The ROADSAVER Carotid Stent System is indicated for use in patients with carotid artierial atherosclerotic disease. Refer to instructions for use, contraindications and warnings for additional information.  Roadsaver is manufactured by MicroVention Europe and distributed by Terumo Europe N.V.  All brand names are a Trademark or registered trademarks of TERUMO CORPORATION and their respective owners. CE 0297

References

  1. DATA ON FILE Microvention Inc.
  2. Hopf-Jensen, S. et al.. Initial clinical experience with the micromesh Roadsaver carotid artery stent for the treatment of patients with symptomatic carotid artery disease. J Endovasc Ther 22, 220–5 (2015).
  3. Nerla, R. et al. Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres: clinical results of a multidisciplinary approach. EuroIntervention 12, e677-83 (2016).
  4. Hopf-Jensen, S. et al. Initial clinical experience with the micromesh Roadsaver carotid artery stent for the treatment of patients with symptomatic carotid artery disease. J Endovasc Ther 22, 220–5 (2015).
  5. Kedev, S. et al. Safety of Slender 5Fr Transradial Approach for Carotid Artery Stenting With a Novel Nitinol Double-Layer Micromesh Stent. Am J Cardiol 116, 977–81 (2015).
  6. Ruffino, M. A. et al. Early Embolization After Carotid Artery Stenting with Mesh-Covered Stent: Role of Diffusion-Weighted Magnetic Resonance Imaging as Pre-procedural Predictor and Discriminant Between Intra- and Post-procedural Events. Cardiovasc Intervent Radiol 42, 812–819 (2019).
  7. PD110729 Roadsaver Instructions for use.

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