Manufacturer > Cook Medical > Devices > Advance® ATB PTA Dilatation Catheter

Advance® ATB PTA Dilatation Catheter

Device-Type

PTA Ballons

Targated Speciality

Cardiovascular

Manufacturer

Cook Medical

Used in Procedure

Any Procedure


The ATB ADVANCE PTA Dilatation Catheter is a double-lumen catheter with a balloon near its distal tip. The catheter consists of two independent lumens, which are labeled “DISTAL” and “BALLOON.” The distal lumen extends the length of the catheter and is used for placement of wire guides. The balloon lumen is used to expand the balloon. Inscribed on the tip of the manifold are the balloon diameter (mm) and the balloon length (cm).

The balloon is manufactured from an extra-thinwall, high-strength, minimally- compliant material. Particular care should be taken in handling the balloon to prevent damage. It will inflate to the indicated size parameters when utilizing proper pressure recommendations. Adhere to balloon inflation pressure parameters indicated in. Refer to label for further information. Use of a pressure gauge is recommended to monitor inflation pressures.

Gold, radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .035 inch (0.89 mm) wire guides.

Safety informations

INTENDED USE

The ATB ADVANCE PTA Dilatation Catheter has been designed for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB is also intended for post dilatation of balloon-expandable peripheral vascular stents. The ATB ADVANCE was tested on the bench with Palmaz®* Balloon-Expandable Stents.

The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.


CONTRAINDICATIONS

None known


WARNINGS

• Do not exceed rated burst pressure.1 Rupture of balloon may occur. Adhere to balloon inflation pressure parameters . Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall. Use of a pressure gauge is recommended to monitor inflation pressures.

• Do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked “DISTAL.” Rupture may occur.

The burst pressure data was analyzed using factors for a one-sided tolerance to determine with 95% confidence that 99.9% of these balloons would not burst at or below the calculated rated burst pressure.


PRECAUTIONS

• The ATB ADVANCE PTA Dilatation Catheter has been designed for introduction into the vascular system utilizing percutaneous (Seldinger) technique. Alternatively, an introducer sheath may be utilized. Refer to label information for the appropriate introducer sheath size.

• The balloon is constructed of a heat-sensitive material. Do not heat or attempt to shape the catheter tip.

• In heavily scarred access sites, use of an introducer sheath is recommended.

• Manipulate catheter using fluoroscopic control.

• Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.

• Use the catheter prior to the “Do Not Use After” date specified on the package.

• The catheter is not intended for the delivery of stents.

• All stents should be deployed in accordance with the manufacturer‘s indications and instructions for use.

Potential adverse events

• Air embolism

• Aneurysm

• Arrhythmias

• Arteriovenous fistula

• Death

• Drug reactions, allergic reaction to contrast medium

• Hemorrhage or hematoma

• Hypo/hypertension

• Infection and pain at insertion site

• Systemic embolization


Device Documents

Related Device SKUs

* Select 2 or more (upto 4) SKUs to compare.
SKU Name Device SKUs Model Catheter Length Accepts Wire Guide Diameter inch Inflated Balloon Diameter mm Balloon Length cm Compatible Sheath Fr Rated Burst Pressure atm
ATB PTA Dilatation Catheter
G31251 40 cm .035 5 4 5.0 15
ATB PTA Dilatation Catheter
G26884 40 cm .035 6 2 5.0 15
ATB PTA Dilatation Catheter
G26885 40 cm .035 6 4 5.0 15
ATB PTA Dilatation Catheter
G26887 40 cm .035 7 4 5.0 15
ATB PTA Dilatation Catheter
G26889 40 cm .035 8 4 6.0 15
ATB PTA Dilatation Catheter
G31192 40 cm .035 10 4 7.0 14
ATB PTA Dilatation Catheter
G44143 40 cm .035 14 4 8.0 8
ATB PTA Dilatation Catheter
G26891 80 cm .035 4 2 5.0 15
ATB PTA Dilatation Catheter
G26892 80 cm .035 4 4 5.0 15
ATB PTA Dilatation Catheter
G26893 80 cm .035 5 2 5.0 15
ATB PTA Dilatation Catheter
G26894 80 cm .035 5 4 5.0 15
ATB PTA Dilatation Catheter
G30216 80 cm .035 5 6 5.0 15
ATB PTA Dilatation Catheter
G26895 80 cm .035 6 2 5.0 15
ATB PTA Dilatation Catheter
G26896 80 cm .035 6 6 5.0 15
ATB PTA Dilatation Catheter
G26898 80 cm .035 6 8 5.0 15
ATB PTA Dilatation Catheter
G26899 80 cm .035 7 2 6.0 15
ATB PTA Dilatation Catheter
G26900 80 cm .035 7 4 6.0 15
ATB PTA Dilatation Catheter
G26901 80 cm .035 7 6 6.0 15
ATB PTA Dilatation Catheter
G26902 80 cm .035 8 2 6.0 15
ATB PTA Dilatation Catheter
G26904 80 cm .035 8 4 6.0 15
ATB PTA Dilatation Catheter
G26905 80 cm .035 8 6 6.0 15
ATB PTA Dilatation Catheter
G30220 80 cm .035 9 2 7.0 14
ATB PTA Dilatation Catheter
G26906 80 cm .035 9 4 7.0 14
ATB PTA Dilatation Catheter
G36350 80 cm .035 9 6 7.0 14
ATB PTA Dilatation Catheter
G26890 80 cm .035 10 4 7.0 14
ATB PTA Dilatation Catheter
G44144 80 cm .035 12 4 8.0 8
ATB PTA Dilatation Catheter
G44145 80 cm .035 14 4 8.0 8
ATB PTA Dilatation Catheter
G26868 120 cm .035 10 4 7.0 14
ATB PTA Dilatation Catheter
G23015 120 cm .035 14 2 8.0 14
  • Model : G31251
  • Procedure : -
  • Catheter Length : 40 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 5
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26884
  • Procedure : -
  • Catheter Length : 40 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 6
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26885
  • Procedure : -
  • Catheter Length : 40 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 6
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26887
  • Procedure : -
  • Catheter Length : 40 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 7
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26889
  • Procedure : -
  • Catheter Length : 40 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 8
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 6.0
  • Rated Burst Pressure atm : 15
  • Model : G31192
  • Procedure : -
  • Catheter Length : 40 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 10
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 7.0
  • Rated Burst Pressure atm : 14
  • Model : G44143
  • Procedure : -
  • Catheter Length : 40 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 14
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 8.0
  • Rated Burst Pressure atm : 8
  • Model : G26891
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 4
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26892
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 4
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26893
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 5
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26894
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 5
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G30216
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 5
  • Balloon Length cm : 6
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26895
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 6
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26896
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 6
  • Balloon Length cm : 6
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26898
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 6
  • Balloon Length cm : 8
  • Compatible Sheath Fr : 5.0
  • Rated Burst Pressure atm : 15
  • Model : G26899
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 7
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 6.0
  • Rated Burst Pressure atm : 15
  • Model : G26900
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 7
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 6.0
  • Rated Burst Pressure atm : 15
  • Model : G26901
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 7
  • Balloon Length cm : 6
  • Compatible Sheath Fr : 6.0
  • Rated Burst Pressure atm : 15
  • Model : G26902
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 8
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 6.0
  • Rated Burst Pressure atm : 15
  • Model : G26904
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 8
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 6.0
  • Rated Burst Pressure atm : 15
  • Model : G26905
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 8
  • Balloon Length cm : 6
  • Compatible Sheath Fr : 6.0
  • Rated Burst Pressure atm : 15
  • Model : G30220
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 9
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 7.0
  • Rated Burst Pressure atm : 14
  • Model : G26906
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 9
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 7.0
  • Rated Burst Pressure atm : 14
  • Model : G36350
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 9
  • Balloon Length cm : 6
  • Compatible Sheath Fr : 7.0
  • Rated Burst Pressure atm : 14
  • Model : G26890
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 10
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 7.0
  • Rated Burst Pressure atm : 14
  • Model : G44144
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 12
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 8.0
  • Rated Burst Pressure atm : 8
  • Model : G44145
  • Procedure : -
  • Catheter Length : 80 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 14
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 8.0
  • Rated Burst Pressure atm : 8
  • Model : G26868
  • Procedure : -
  • Catheter Length : 120 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 10
  • Balloon Length cm : 4
  • Compatible Sheath Fr : 7.0
  • Rated Burst Pressure atm : 14
  • Model : G23015
  • Procedure : -
  • Catheter Length : 120 cm
  • Accepts Wire Guide Diameter inch : .035
  • Inflated Balloon Diameter mm : 14
  • Balloon Length cm : 2
  • Compatible Sheath Fr : 8.0
  • Rated Burst Pressure atm : 14

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