Embolic protection
SpiderFX
by EV3, Inc
A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.
Where to buy SpiderFX
We do not have contact details for EV3, Inc yet. Send a request and we will route it to the right person for your country.
SpiderFX models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| SPD2-US-030-190 | Outer Diameter 3.0 mm; Length 190.0 cm | Not stated | Available |
| SPD2-US-030-320 | Outer Diameter 3.0 mm; Length 320.0 cm | Not stated | Available |
| SPD2-US-040-190 | Outer Diameter 4.0 mm; Length 190.0 cm | Not stated | Available |
| SPD2-US-040-320 | Outer Diameter 4.0 mm; Length 320.0 cm | Not stated | Available |
| SPD2-US-050-190 | Length 190.0 cm; Outer Diameter 5.0 mm | Not stated | Available |
| SPD2-US-050-320 | Length 320.0 cm; Outer Diameter 5.0 mm | Not stated | Available |
| SPD2-US-060-190 | Length 190.0 cm; Outer Diameter 6.0 mm | Not stated | Available |
| SPD2-US-060-320 | Outer Diameter 6.0 mm; Length 320.0 cm | Not stated | Available |
| SPD2-US-070-190 | Length 190.0 cm; Outer Diameter 7.0 mm | Not stated | Available |
| SPD2-US-070-320 | Outer Diameter 7.0 mm; Length 320.0 cm | Not stated | Available |
FDA clearances
- 510(k) K111010 October 2011
- 510(k) K063204 November 2006
Procedures that use embolic protection
Frequently asked questions
What is SpiderFX used for?
A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.
Who makes SpiderFX?
SpiderFX is made by EV3, Inc. It is listed under embolic protection devices in our device library.
What sizes does SpiderFX come in?
Sizes listed for SpiderFX: Length: 190–320 cm; Outer Diameter: 3–7 mm. Confirm availability with the manufacturer's instructions for use.
Is SpiderFX MRI safe?
The FDA device database entry for SpiderFX does not state its MRI safety status. Check the labeling before MRI.
Is SpiderFX FDA cleared?
SpiderFX is covered by FDA submissions K063204, K111010.
How do I contact a EV3, Inc sales representative?
EV3, Inc has not listed representatives on LA Vascular yet. Visit the EV3, Inc company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.