PRODUCT PORTFOLIO

Silene™

A covered peripheral stent platform developed for demanding vascular intervention environments.

Silene™ product features and medical device

CLINICAL POSITIONING

Purpose-built vascular technology.

Silene™ extends InSitu's covered-stent engineering experience into the peripheral portfolio. Detailed clinical positioning will be presented in accordance with applicable regulatory authorization and approved product documentation.

Product availability and regulatory status vary by market. Information presented here is a portfolio overview and not medical advice or instructions for use.

CLINICAL EXPERIENCE

Silene Case Studies

Explore Silene™ clinical experiences, with procedural insights, original imaging and reported outcomes.

DESIGN & PERFORMANCE

An ideal device for emergency use situations.

  • Optimal trackability and deliverability in the tortuous anatomy
  • Excellent flexibility and superior navigability in challenging lesions
  • ePTFE polymer with proprietary micro-porous technology
  • Mono layer graft stent with a U.S. Patented intravascular hybrid open-closed cell design
  • Proprietary delivery catheter balloon pillowing technology
  • Superior vessel conformance
  • Optimum radial strength
  • Lowest pre-mounted crimped profile

PRODUCT INFORMATION

Technical Data

SpecificationDescription
Stent DesignDirect-Stent® - Patented Hybrid Cell Design
Stent MaterialL605 Cobalt Chromium Alloy
Stent Covering PolymerePTFE Microporous Polymer, IND 90 - 120 μm
Wall Thickness0.08 mm/0.003"
Balloon SystemOver the Wire (OTW)
Balloon MaterialSemi-Compliant - Nylon Blend
Optimal Deployment Pressure9 ATM
**Nominal Pressure7 ATM
Rated Burst Pressure10 ATM
Shaft Size5/6F
*Minimum Sheath SizeØ6 - 7 mm: 6Fr; Ø8 - 9 mm: 8Fr; Ø10 - 12 mm: 9Fr
Pre-mounted Profile1.7 - 3.0 mm
Tip Entry Profile0.039"
Recommended Guidewire0.035"
Delivery Catheter Length~ 130 cm
Stent Length14 - 70 mm
Stent Ends Flaring6, 7 → 9 mm; 8, 9, 10 → 14 mm; 12 → 16 mm
Radial Force10 - 9 mm | 2.0 N Force

* See individual manufacturer for Sheath Size Fr equivalent.

** Assure full deployment of stent. Deployment pressures should be based on lesion characteristics.

Technical data should be read with the applicable approved Instructions for Use. Specifications and availability may vary by market.

CONFIGURATIONS

Ordering Information

Stent Diameter (mm)Stent Length (mm)Ordering Number
6.015, 25, 35, 50, 707560XX
7.015, 25, 35, 50, 707570XX
8.015, 24, 32, 50, 707580XX
9.015, 24, 32, 50, 707590XX
10.015, 23, 31, 48, 6575100XX
12.014, 23, 31, 48, 6575120XX

XX denotes the selected length, including a leading zero where shown. Example: 6.0 mm diameter × 15 mm length: 756015.

Confirm configurations and ordering information against the current approved product documentation.

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