Flow-Diverter Stents
Surpass Streamline Flow Diverter
Indications for Use
The Surpass Streamline Flow Diverter is indicated for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.3 mm.
Key Specifications
- Self-expandable braided implant made of cobalt chromium braids interwoven with platinum-tungsten wires for fluoroscopic visualization
- Diameters: 3 mm, 4 mm, 5 mm
- Lengths: 15 mm, 20 mm, 25 mm (for 3 mm and 4 mm diameters); 15 mm, 20 mm, 25 mm, 30 mm, 40 mm, 50 mm (for 4 mm diameter); 20 mm, 25 mm, 30 mm, 40 mm, 50 mm (for 5 mm diameter)
- Unconstrained implant outer diameters: >3.5 mm (3 mm device), >4.4 mm (4 mm device), >5.3 mm (5 mm device)
- Maximum vessel diameter: 3.5 mm (3 mm device), 4.4 mm (4 mm device), 5.3 mm (5 mm device)
- Recommended minimum vessel diameter: 2.5 mm (3 mm device), 3.4 mm (4 mm device), 4.3 mm (5 mm device)
- Average decrease in length from inside delivery system to fully expanded: 33% (3 mm), 38% (4 mm), 28% (5 mm)
- Delivery system includes Surpass Streamline outer catheter with single radiopaque marker at distal tip and hydrophilic coating on distal section
- Surpass Streamline pusher with radiopaque tip marker and proximal pusher marker; implant loaded between markers
- Preloaded in delivery system with Y-Valve/Rotating Hemostatic Valve (RHV)
- Sterile via ethylene oxide (EO) process; single use only
- MR Conditional: safe in 1.5 T or 3.0 T static magnetic fields with maximum spatial gradient 2,500 gauss/cm and SAR 4 W/kg; maximum temperature rise <3.4°C after 15 minutes; image artifact ~10 mm
- Compatible with Stryker Neurovascular AXS Catalyst 5 guiding catheter (UPN M003IC0581150)
- Compatible guidewires: Stryker Neurovascular Synchro2 (e.g., UPN M00326410), Synchro-14 (e.g., UPN M00313010), Boston Scientific Transend EX (e.g., UPN M001468050)
- Requires 6F or greater introducer sheath
- Designed for use under fluoroscopy; can be recaptured and repositioned prior to full deployment
- Select device length at least 10 mm longer than aneurysm neck for 5 mm coverage on each side
Description
The Surpass Streamline Flow Diverter system is comprised of a self-expandable braided device preloaded in a Delivery System. The system consists of the Surpass Flow Diverter implant, Surpass Streamline outer, and Surpass Streamline pusher. The braided Surpass Flow Diverter, made of cobalt chromium with platinum-tungsten visualization wires, expands to the vessel lumen upon deployment to divert blood flow away from the intracranial aneurysm. It is shipped sterile and labeled for single use only.