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Formula™ 414 RX Renal Balloon-Expandable Stent


Indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous transluminal renal angioplasty (PTRA) of a de novo or restenotic lesion (≤ 18 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0-7.0 mm. Suboptimal PTRA is defined as ≥ 50% residual stenosis, ≥ 20 mm Hg systolic or ≥ 10 mm Hg mean translesional pressure gradient or flow-limiting dissection.
This product line is serviced by the following clinical division(s):

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Specifications

Order Number Reference Part Number Instructions
for Use (IFU)
MR
Status
Accepts Wire Guide Diameter inch Stent Diameter
mm
Stent Length
mm
More Info
80 cm Rapid-Exchange Delivery System
G18523 FORX414-14-80-4-12
MR Conditional .014 4 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G18524 FORX414-14-80-4-16
MR Conditional .014 4 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G18525 FORX414-14-80-4-20
MR Conditional .014 4 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56958 FORX414-14-80-5-12
MR Conditional .014 5 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56959 FORX414-14-80-5-16
MR Conditional .014 5 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56960 FORX414-14-80-5-20
MR Conditional .014 5 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56962 FORX414-14-80-6-12
MR Conditional .014 6 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56961 FORX414-14-80-6-16
MR Conditional .014 6 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56963 FORX414-14-80-6-20
MR Conditional .014 6 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56964 FORX414-14-80-7-12
MR Conditional .014 7 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56965 FORX414-14-80-7-16
MR Conditional .014 7 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56967 FORX414-14-80-7-20
MR Conditional .014 7 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
135 cm Rapid-Exchange Delivery System
G18526 FORX414-14-135-4-12
MR Conditional .014 4 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G18527 FORX414-14-135-4-16
MR Conditional .014 4 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G18528 FORX414-14-135-4-20
MR Conditional .014 4 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56966 FORX414-14-135-5-12
MR Conditional .014 5 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56968 FORX414-14-135-5-16
MR Conditional .014 5 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56969 FORX414-14-135-5-20
MR Conditional .014 5 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56970 FORX414-14-135-6-12
MR Conditional .014 6 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56971 FORX414-14-135-6-16
MR Conditional .014 6 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56972 FORX414-14-135-6-20
MR Conditional .014 6 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56973 FORX414-14-135-7-12
MR Conditional .014 7 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56974 FORX414-14-135-7-16
MR Conditional .014 7 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56975 FORX414-14-135-7-20
MR Conditional .014 7 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12

Documents

Quick Reference

Formula clinical trial summary card

PI-BUSM-RDSC-EN-201212_M3.pdf »

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