Healthcare Professionals
SpiderFX Embolic Protection Device
Peripheral Interventions
Overview
Capture and remove debris that dislodges during interventional procedures with the SpiderFX™ embolic protection device. Debris can embolise downstream, blocking smaller vessels, resulting in procedural complications and poor patient outcomes. The device's braided nitinol basket is available in a number of sizes that allow for optimal vessel sizing. Choose the only embolic protection device indicated for use in lower extremity, carotid, and saphenous vein graft interventions.
Indications
Lower Extremity (LE) Interventions
The SpiderFX™ Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material in conjunction with the TurboHawk™/HawkOne™ Peripheral Plaque Excision System, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities. The vessel diameter at the filter basket placement site should be between 3.0 mm and 6.0 mm.
Carotid Interventions
The SpiderFX™ Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.
Saphenous Vein Graft (SVG) Interventions
The SpiderFX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0mm to 6.0mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral vasculature.
Product Details
Debris matters
Debris can occur with any endovascular procedure and may lead to complications or poor patient outcomes.
Carotid Interventions: Distal embolisation can lead to cerebral ischemia and stroke.
SVG Interventions: Distal embolisation can lead to myocardial ischemia, infarction or slow flow/no reflow.
Lower Extremity Interventions: Distal embolisation can result in occlusion of smaller distal vessels, limb ischemia and limb loss. Patients with critical limb ischemia or single vessel run-off are at a greater risk of an embolic event, as are patients with complex lesion morphology such as severe calcium.
Delivery of choice
The SpiderFX™ device can be delivered over any 0.014” or 0.018” guidewire, allowing physicians to choose their method of delivery for successful placement even in challenging access situations.
Vessel of choice
SpiderFX™ device has a unique braided nitinol filter that conforms to the vessel wall and maintains full-wall apposition during the intervention. Flow is directed into the filter’s conical design, effectively capturing debris while maintaining blood flow.
A gold tungsten loop around the mouth of the filter and radiopaque markers allow for precise positioning and verification of apposition before proceeding with the intervention.
The capture wire (available in 190 cm and 320 cm) rotates and moves longitudinally independent of the filter for enhanced stability during the procedure.
Extensive SpiderFX™ Portfolio
SpiderFX™ device is available in a variety of sizes (3 mm to 7 mm) for optimal fit and apposition in a range of vessels.
Manuals and Technical Guides
Instructions for Use
Find this technical manual in the product labeling supplied with each device.
ORDERING INFORMATION
| Product Catalogue | Capture Wire | Delivery Catheter |
Recovery End | Guide Catheter/Sheath | |||
|---|---|---|---|---|---|---|---|
| Number (1/Box) | Filter Size (mm) |
Target Vessel Size (mm) |
Wire Length OTW/RX cm) |
Wire Diameter (in/mm) |
Cross Profile (F) |
Diameter (F) |
Minimum ID (in) |
| SPD2-030-190 | 3.0 | 2.0-3.0 | 190 | 0.014/0.36 | 3.2 | 4.2 | 0.066 |
| SPD2-030-320 | 3.0 | 2.0-3.0 | 320/190 | 0.014/0.36 | 3.2 | 4.2 | 0.066 |
| SPD2-040-190 | 4.0 | 3.1-4.0 | 190 | 0.014/0.36 | 3.2 | 4.2 | 0.066 |
| SPD2-040-320 | 4.0 | 3.1-4.0 | 320/190 | 0.014/0.36 | 3.2 | 4.2 | 0.066 |
| SPD2-050-190 | 5.0 | 4.1-5.0 | 190 | 0.014/0.36 | 3.2 | 4.2 | 0.066 |
| SPD2-050-320 | 5.0 | 4.1-5.0 | 320/190 | 0.014/0.36 | 3.2 | 4.2 | 0.066 |
| SPD2-060-190 | 6.0 | 4.5-6.0 | 190 | 0.014/0.36 | 3.2 | 4.2 | 0.066 |
| SPD2-060-320 | 6.0 | 4.5-6.0 | 320/190 | 0.014/0.36 | 3.2 | 4.2 | 0.066 |
| SPD2-070-190 | 7.0 | 5.5-7.0 | 190 | 0.014/0.36 | 3.2 | 4.2 | 0.066 |
| SPD2-070-320 | 7.0 | 5.5-7.0 | 320/190 | 0.014/0.36 | 3.2 | 4.2 | 0.066 |
See product catalog for complete, detailed product information.