Intrasaccular And Aneurysm Neck Reconstruction Device
PulseRider Aneurysm Neck Reconstruction Device
Indications for Use
PulseRider® is indicated for use with neurovascular embolic coils in patients ≥ 18 years of age for the treatment of unruptured wide-necked intracranial aneurysms with neck widths ≥ 4 mm or dome to neck ratio < 2 originating on or near a vessel bifurcation of the basilar tip or carotid terminus with at least a portion of the aneurysm neck overlapping the lumen of the parent artery. The inflow vessels should have diameters from 2.7 mm to 4.5 mm.
Key Specifications
- Self-expanding nitinol implant designed to retain embolic coils at or near a vessel bifurcation
- Composed of torque device, delivery wire, introducer, and implant
- Delivery wire: working length 190 cm, nominal diameter 0.36 mm (0.014"), distal 20” (51 cm) hydrophilic coating
- Introducer: working length 67 cm, nominal diameter 1.32 mm (0.052")
- Compatible with microcatheters having minimum inner diameter of 0.53 mm (0.021")
- Insulated for electrolytic detachment using commercially available power supplies
- Available in T-shape and Y-shape configurations with 8 mm and 10 mm wide arches
- Anchor base sizes accommodate parent arteries from 2.7 mm to 4.5 mm
- Implant materials: Nitinol base, Platinum/Iridium alloy radiopaque markers, Gold-Tin alloy solder, Stainless Steel detachment zone, Parylene coating
- Delivery wire materials: Stainless Steel core, Platinum/Iridium alloy markers, Gold-Tin alloy solder, Stainless Steel detachment zone, Parylene and Polyester Heatshrink coatings, Hydrophilic coating on distal 20"
- Arch width selection: 8 mm or 10 mm based on aneurysm neck width and branch angles
- Parent vessel diameter selection: 2.7-3.5 mm or 3.5-4.5 mm, measured approximately 1 cm below aneurysm neck
- Implant catalog numbers: 201-D, 203-D, 211-D, 213-D (T-shape); 301-D, 303-D, 311-D, 313-D (Y-shape)
- MR Conditional: Static magnetic field of 1.5-Tesla and 3-Tesla, maximum spatial gradient 3,000-gauss/cm, maximum SAR 4 W/kg (whole body) and 3.2 W/kg (head), expected temperature rise 3.2°C after 15 minutes
- Image artifact extends approximately 5 mm from implant in 3-Tesla MR system using gradient echo sequence
- Sterilized by ethylene oxide gas, single-use, provided sterile in sealed pouch
- Coil delivery microcatheter compatibility: Maximum outer diameter 2.0 F (0.66 mm)
- Deployment: Proximal foreshortening up to 2.5 mm, distal expansion to labeled arch width
Description
The PulseRider® is a self-expanding nitinol implant designed to retain embolic coils at or near a vessel bifurcation as specified in the Indications for Use. PulseRider® is comprised of the torque device, delivery wire, introducer, and implant.