Peripheral stents
TIGRIS Vascular Stent
by W. L. Gore & Associates, 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.
TIGRIS Vascular Stent 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 |
|---|---|---|---|
| PHA050301A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 5 mm; Length 30 mm | MR Conditional | Available |
| PHA050302A | Length 30 mm; Lumen/Inner Diameter 5 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA050401A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 5 mm; Length 40 mm | MR Conditional | Available |
| PHA050402A | Length 40 mm; Lumen/Inner Diameter 5 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA050601A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 5 mm; Length 60 mm | MR Conditional | Available |
| PHA050602A | Length 60 mm; Lumen/Inner Diameter 5 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA050801A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 5 mm; Length 80 mm | MR Conditional | Available |
| PHA050802A | Length 80 mm; Lumen/Inner Diameter 5 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA051001A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 5 mm; Length 100 mm | MR Conditional | Available |
| PHA051002A | Length 100 mm; Lumen/Inner Diameter 5 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA060301A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 6 mm; Length 30 mm | MR Conditional | Available |
| PHA060302A | Length 30 mm; Lumen/Inner Diameter 6 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA060401A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 6 mm; Length 40 mm | MR Conditional | Available |
| PHA060402A | Length 40 mm; Lumen/Inner Diameter 6 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA060601A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 6 mm; Length 60 mm | MR Conditional | Available |
| PHA060602A | Length 60 mm; Lumen/Inner Diameter 6 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA060801A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 6 mm; Length 80 mm | MR Conditional | Available |
| PHA060802A | Length 80 mm; Lumen/Inner Diameter 6 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA061001A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 6 mm; Length 100 mm | MR Conditional | Available |
| PHA061002A | Length 100 mm; Lumen/Inner Diameter 6 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA070301A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 7 mm; Length 30 mm | MR Conditional | Available |
| PHA070302A | Length 30 mm; Lumen/Inner Diameter 7 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA070401A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 7 mm; Length 40 mm | MR Conditional | Available |
| PHA070402A | Length 40 mm; Lumen/Inner Diameter 7 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA070601A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 7 mm; Length 60 mm | MR Conditional | Available |
| PHA070602A | Length 60 mm; Lumen/Inner Diameter 7 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA070801A | Length 80 mm; Lumen/Inner Diameter 7 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA070802A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 7 mm; Length 80 mm | MR Conditional | Available |
| PHA071001A | Length 100 mm; Lumen/Inner Diameter 7 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| PHA071002A | Catheter Gauge 6 Fr; Lumen/Inner Diameter 7 mm; Length 100 mm | MR Conditional | Available |
FDA clearances
- PMA P160004 July 2018
Procedures that use peripheral stents
Frequently asked questions
What is TIGRIS Vascular Stent 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 TIGRIS Vascular Stent?
TIGRIS Vascular Stent is made by W. L. Gore & Associates, Inc.. It is listed under peripheral artery stents and covered stents in our device library.
What sizes does TIGRIS Vascular Stent come in?
Sizes listed for TIGRIS Vascular Stent: Length: 30–100 mm; Lumen/Inner Diameter: 5–7 mm; Catheter Gauge: 6 Fr. Confirm availability with the manufacturer's instructions for use.
Is TIGRIS Vascular Stent MRI safe?
The FDA device database lists TIGRIS Vascular Stent as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is TIGRIS Vascular Stent FDA cleared?
TIGRIS Vascular Stent is covered by FDA submission P160004.
How do I contact a W. L. Gore & Associates, Inc. sales representative?
W. L. Gore & Associates, Inc. has not listed representatives on LA Vascular yet. Visit the W. L. Gore & Associates, 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.