Flow-Diverter Stents
Pipeline™ Flex Embolization Device
Indications for Use
The Pipeline™ Flex embolization device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex embolization device is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.
Key Specifications
- Permanent implant combined with a guidewire-based delivery system
- Braided, multi-alloy mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires
- Approximately 30% metal coverage of the arterial wall surface area
- Designed for placement in a parent vessel across the neck of an intracranial aneurysm
- Expanded or unconstrained diameter is 0.25 mm larger than the labeled diameter
- Mounted on a 304 stainless steel micro-guidewire approximately 200 cm long
- Compressed inside an introducer sheath
- Delivered through compatible micro catheter of 0.027 inch (0.69 mm) inside diameter, at least 135 cm in length
- Tip coil made of platinum-tungsten alloy
- Proximal bumper is a platinum-iridium alloy
- Tip, distal, and proximal solder joints are tin-silver
- Protective sleeves protect the distal portion of the braid during advancement through micro catheter
- Proximal bumper and resheathing pad allow pushing and resheathing of the device
- Resheathing marker for fluoroscopic visualization of resheathing limit
- Delivery wire has a fluorosafe marker no further than 125 cm from the distal end
- Labeled diameters: 2.50 mm to 5.00 mm
- Self-expanded diameters: 2.75 mm to 5.25 mm
- Labeled lengths: 10 mm to 35 mm, varying by diameter
- MR Conditional: Static magnetic field of 3 Tesla or less, spatial gradient field of 720 Gauss/cm or less, maximum whole-body-averaged SAR of 4.0 W/kg for 15 minutes
- Non-clinical testing showed temperature rise <0.6°C under specified MR conditions
- Artifact: Worst case maximum <4 mm at 3.0 Tesla for 5.0 mm device
- Provided sterile for single use only
- Foreshortens substantially (50-60%) during deployment
Description
The Pipeline™ Flex embolization device consists of a permanent implant combined with a guidewire based delivery system. The Pipeline™ Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The woven wires of the device provide approximately 30% metal coverage of the arterial wall surface area. The implant is designed for placement in a parent vessel across the neck of an intracranial aneurysm (IA). The expanded or unconstrained diameter is 0.25 mm larger than the labeled diameter. The Pipeline™ Flex embolization device implant is mounted on a 304 stainless steel micro-guidewire approximately 200 cm long and compressed inside an introducer sheath. The Pipeline™ Flex embolization device is designed to be delivered only through a compatible micro catheter of 0.027 inch (0.69 mm) inside diameter at least 135 cm in length.