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Formula 418® 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):

The products on this website are available for sale in the United States. Reference Part Numbers are not the same in all countries/regions. For products available in other countries, please choose one of our other websites from the region selector at the top of the site or contact your local Cook Medical representative.

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 Over-the-Wire Delivery System
G56605 FOR418-18-80-4-12
.018 4 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56606 FOR418-18-80-4-16
.018 4 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56607 FOR418-18-80-4-20
.018 4 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56631 FOR418-18-80-5-12
.018 5 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56609 FOR418-18-80-5-16
.018 5 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56610 FOR418-18-80-5-20
.018 5 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56611 FOR418-18-80-6-12
.018 6 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56613 FOR418-18-80-6-16
.018 6 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56614 FOR418-18-80-6-20
.018 6 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56615 FOR418-18-80-7-12
.018 7 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
6.0/7.0
Nominal/ Rated Burst Pressure atm
8/12
G56616 FOR418-18-80-7-16
.018 7 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
6.0/7.0
Nominal/ Rated Burst Pressure atm
8/12
G56617 FOR418-18-80-7-20
.018 7 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
6.0/7.0
Nominal/ Rated Burst Pressure atm
8/12
135 cm Over-the-Wire Delivery System
G56618 FOR418-18-135-4-12
.018 4 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56619 FOR418-18-135-4-16
.018 4 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56620 FOR418-18-135-4-20
.018 4 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56621 FOR418-18-135-5-12
.018 5 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56623 FOR418-18-135-5-16
.018 5 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56624 FOR418-18-135-5-20
.018 5 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56625 FOR418-18-135-6-12
.018 6 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56626 FOR418-18-135-6-16
.018 6 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56627 FOR418-18-135-6-20
.018 6 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
5.0/6.0
Nominal/ Rated Burst Pressure atm
8/12
G56628 FOR418-18-135-7-12
.018 7 12 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
6.0/7.0
Nominal/ Rated Burst Pressure atm
8/12
G56629 FOR418-18-135-7-16
.018 7 16 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
6.0/7.0
Nominal/ Rated Burst Pressure atm
8/12
G56630 FOR418-18-135-7-20
.018 7 20 Expand »
Additional Specs
Description
-
Sheath/ Guiding Catheter Fr
6.0/7.0
Nominal/ Rated Burst Pressure atm
8/12

Documents

Physician Procedure Guide

Formula clinical trial summary card

PI-BUSM-RDSC-EN-201212_M3.pdf »
English

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