Peripheral stents
EverFlex
by EV3, Inc
A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.
EverFlex 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 |
|---|---|---|---|
| PRB35-06-020-080 | Length 20.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-06-020-120 | Length 20.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-06-030-080 | Length 30.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-06-030-120 | Length 30.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-06-040-080 | Catheter Gauge 6.0 Fr; Length 40.0 mm | Not stated | Available |
| PRB35-06-040-120 | Catheter Gauge 6.0 Fr; Length 40.0 mm | Not stated | Available |
| PRB35-06-060-080 | Catheter Gauge 6.0 Fr; Length 60.0 mm | Not stated | Available |
| PRB35-06-080-080 | Length 80.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-06-100-080 | Length 100.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-06-100-120 | Length 100.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-06-120-080 | Length 120.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-06-120-120 | Catheter Gauge 6.0 Fr; Length 120.0 mm | Not stated | Available |
| PRB35-06-150-080 | Length 150.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-06-150-120 | Catheter Gauge 6.0 Fr; Length 150.0 mm | Not stated | Available |
| PRB35-07-020-080 | Catheter Gauge 6.0 Fr; Length 20.0 mm | Not stated | Available |
| PRB35-07-020-120 | Length 20.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-07-030-080 | Catheter Gauge 6.0 Fr; Length 30.0 mm | Not stated | Available |
| PRB35-07-030-120 | Length 30.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-07-040-080 | Length 40.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-07-040-120 | Catheter Gauge 6.0 Fr; Length 40.0 mm | Not stated | Available |
| PRB35-07-060-080 | Catheter Gauge 6.0 Fr; Length 60.0 mm | Not stated | Available |
| PRB35-07-080-080 | Length 80.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-07-100-080 | Catheter Gauge 6.0 Fr; Length 100.0 mm | Not stated | Available |
| PRB35-07-100-120 | Catheter Gauge 6.0 Fr; Length 100.0 mm | Not stated | Available |
| PRB35-07-120-120 | Length 120.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-07-150-120 | Catheter Gauge 6.0 Fr; Length 150.0 mm | Not stated | Available |
| PRB35-08-020-080 | Catheter Gauge 6.0 Fr; Length 20.0 mm | Not stated | Available |
| PRB35-08-020-120 | Catheter Gauge 6.0 Fr; Length 20.0 mm | Not stated | Available |
| PRB35-08-030-080 | Length 30.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-08-030-120 | Length 30.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-08-040-080 | Catheter Gauge 6.0 Fr; Length 40.0 mm | Not stated | Available |
| PRB35-08-040-120 | Catheter Gauge 6.0 Fr; Length 40.0 mm | Not stated | Available |
| PRB35-08-060-080 | Length 60.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-08-080-080 | Length 80.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-08-100-080 | Catheter Gauge 6.0 Fr; Length 100.0 mm | Not stated | Available |
| PRB35-08-100-120 | Catheter Gauge 6.0 Fr; Length 100.0 mm | Not stated | Available |
| PRB35-08-120-080 | Catheter Gauge 6.0 Fr; Length 120.0 mm | Not stated | Available |
| PRB35-08-120-120 | Length 120.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| PRB35-08-150-080 | Catheter Gauge 6.0 Fr; Length 150.0 mm | Not stated | Available |
| PRB35-08-150-120 | Catheter Gauge 6.0 Fr; Length 150.0 mm | Not stated | Available |
FDA clearances
- PMA P110023 July 2012
Procedures that use peripheral stents
Frequently asked questions
What is EverFlex used for?
A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.
Who makes EverFlex?
EverFlex is made by EV3, Inc. It is listed under peripheral artery stents and covered stents in our device library.
What sizes does EverFlex come in?
Sizes listed for EverFlex: Catheter Gauge: 6 Fr; Length: 20–150 mm. Confirm availability with the manufacturer's instructions for use.
Is EverFlex MRI safe?
The FDA device database entry for EverFlex does not state its MRI safety status. Check the labeling before MRI.
Is EverFlex FDA cleared?
EverFlex is covered by FDA submission P110023.
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.