POWERSAIL / HIGHSAIL Coronary Dilatation Catheters (US)

Features

See larger view	PLATEAU Balloon Material Provides non-compliance at high pressure without compromising performance Flexibility and conformability for excellent deliverability
See larger view	LOFOLD Balloon Technology Provides a low crossing profile for exceptional lesion cross LOFOLD balloon technology for improved balloon rewrap
See larger view	Soft Tip Design Tapered tip design creates a low entry profile and excellent tip-to-wire conformability for easy lesion access Soft tip provides flexibility for negotiating tortuosity and crossing stent struts
See larger view	Dual Swaged Markers Provide lower profiles than conventional markers
See larger view	FLEXIPUSH Support Wire (POWERSAIL RX) Proximal shaft technology is designed to improve push, flexibility and minimal junction kinking.
See larger view	ELASTICORE Technology (HIGHSAIL OTW) A nitinol wire extending through the transition segment is designed to enhance push efficiency from hub to tip Provides super-elasticity and kink resistance for junction integrity and flexibility

Specifications

Specifications & Part Numbers Table 19 KB

Indications and Important Safety Information

Powersail Coronary Dilatation Catheter

INDICATIONS

The POWERSAIL Coronary Dilatation Catheter is indicated for:

a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction.

c) balloon dilatation of the Guidant MULTI-LINK Stent, MULTI-LINK DUET Stent, MULTI-LINK TRISTAR Stent, MULTI-LINK TETRA Stent or MULTI-LINK ULTRA Stent after implantation. This indication applies to the following balloon sizes and stent lengths:

Balloon Size                              Stent Length

2.5 – 4.0 mm x 8 mm     8 mm

2.5 – 5.0 mm x 13 mm   13 mm

2.5 – 4.0 mm x 15 mm   15 mm

2.5 – 5.0 mm x 18 mm   18 mm

2.5 – 4.0 mm x 23 mm   23 mm

2.5 – 5.0 mm x 28 mm   28 mm

3.0 – 4.0 mm x 33 mm   33 mm

3.0 – 3.5 mm x 33 mm   35 mm

3.0 – 4.0 mm x 33 mm   38 mm

CONTRAINDICATIONS

The POWERSAIL Coronary Dilatation Catheter is not intended to be used:

• in an unprotected left main coronary artery.

• to treat coronary artery spasm in the absence of a significant stenosis.

WARNINGS

This device is intended for one time use only. DO NOT resterilize and/or reuse it, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.

PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication.

PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population   carries special risk.

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

Balloon pressure should not exceed the rated burst pressure (RBP). The RBP is based on results of in vitro testing. At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their RBP. Use of a pressure-monitoring device is recommended to prevent over pressurization.

To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.

Use the catheter prior to the “Use By” date specified on the package.

When the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum and no resistance is felt. If there is resistance, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter.

Never apply extreme bending or twisting force to any section of the catheter in order to prevent kinking or damage/separation of the shaft.

Treatment of moderately or heavily calcified lesions is considered to be moderate risk, with an expected success rate of 60-85% and increases the risk of acute closure, vessel trauma, balloon burst, balloon entrapment and associated complications. If resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter.

In the event of catheter damage/separation, recovery of any portion should be performed based on physician determination of individual patient condition and appropriate retrieval protocol.

PRECAUTIONS

This device should be used only by physicians trained in angiography and percutaneous transluminal coronary angioplasty (PTCA), and/or percutaneous transluminal angioplasty (PTA).

Prior to angioplasty, the dilatation catheter should be examined to verify functionality and ensure that its size is suitable for the specific procedure for which it is to be used.

During the procedure, appropriate anticoagulant and coronary vasodilator therapy must be provided to the patient as needed. Anticoagulant therapy should be continued for a period of time to be determined by the physician after the procedure.

The design and construction of these catheters do not provide the user with distal pressure monitoring capability.

If the surface of the POWERSAIL Coronary Dilatation Catheter becomes dry, wetting with heparinized normal saline will reactivate the coating.

Do not reinsert the POWERSAIL Coronary Dilatation Catheter into the coil dispenser after procedural use.

With 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter. Choosing a larger guiding catheter size may minimize this.

ADVERSE EVENTS

Possible adverse events include, but are not limited to, the following:

• acute myocardial infarction • arrhythmias, including ventricular fibrillation
• arteriovenous fistula • coronary artery spasm • coronary vessel dissection, perforation, rupture or injury • death • drug reactions, allergic reaction to contrast medium • embolism • hemorrhage or hematoma • hypo/hypertension • infection
• restenosis of the dilated vessel • total occlusion of the coronary artery or bypass graft • unstable angina

Indications and Important Safety Information

HIGHSAIL Coronary Dilatation Catheter

INDICATIONS

The HIGHSAIL Coronary Dilatation Catheter is indicated for: 

a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.  

b) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction. 

c) Balloon dilatation of the MULTI-LINK Stent, MULTI-LINK DUET Stent, MULTI-LINK TRISTAR Stent, MULTI-LINK TETRA Stent or MULTI-LINK ULTRA Stent after implantation. This indication applies to the following balloon sizes and stent lengths:  

Balloon Size                                         Stent Length

2.5 – 4.0 mm x 8 mm                 8 mm

2.5 – 5.0 mm x 13 mm               13 mm

2.5 – 4.0 mm x 15 mm               15 mm

2.5 – 5.0 mm x 18 mm               18 mm

2.5 – 4.0 mm x 23 mm               23 mm

2.5 – 5.0 mm x 28 mm               28 mm

3.0 – 4.0 mm x 33 mm               33 mm

3.0 – 3.5 mm x 33 mm               35 mm

3.0 – 4.0 mm x 33 mm               38 mm

CONTRAINDICATIONS

The HIGHSAIL Coronary Dilatation Catheter is not intended to be used: 

• In an unprotected left main coronary artery.

• To treat coronary artery spasm in the absence of a significant stenosis.

WARNINGS AND PRECAUTIONS

Warnings

This device is intended for one time use only. DO NOT resterilize and / or reuse it, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing. 

PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication. 

PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk. 

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

Balloon pressure should not exceed the rated burst pressure (RBP). The RBP is based on results of in vitro testing. At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their RBP. Use of a pressure-monitoring device is recommended to prevent over-pressurization. 

To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis. 

Note the product “Use By” date specified on the package.

When the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum and no resistance is felt. If there is resistance, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.  

Never apply extreme bending or twisting force to any section of the catheter in order to prevent kinking or damage / separation of the shaft. 

Treatment of moderately or heavily calcified lesions is considered to be moderate risk, with an expected success rate of 60% – 85% and increases the risk of acute closure, vessel trauma, balloon burst, balloon entrapment and associated complications. If resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter. 

In the event of catheter damage / separation, recovery of any portion should be performed based on physician determination of individual patient condition and appropriate retrieval protocol.

Precautions

This device should be used only by physicians trained in angiography and percutaneous transluminal coronary angioplasty (PTCA), and / or percutaneous transluminal angioplasty (PTA). 

Prior to angioplasty, the dilatation catheter should be examined to verify functionality and ensure that its size is suitable for the specific procedure for which it is to be used. 

During the procedure, appropriate anticoagulant and coronary vasodilator therapy must be provided to the patient as needed. Anticoagulant therapy should be continued for a period of time to be determined by the physician after the procedure. 

If the surface of the HIGHSAIL Coronary Dilatation Catheter becomes dry, wetting with heparinized normal saline will reactivate the coating. 

Do not reinsert the HIGHSAIL Coronary Dilatation Catheter into the coil dispenser after procedural use. 

With 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter. Choosing a larger guiding catheter size may minimize this.

ADVERSE EVENTS 

Possible adverse events include, but are not limited to, the following: 

• Acute myocardial infarction • Arrhythmias, including ventricular fibrillation
• Arteriovenous fistula • Coronary artery spasm • Coronary vessel dissection, perforation, rupture or injury • Death • Drug reactions, allergic reaction to contrast medium • Embolism • Hemorrhage or hematoma • Hypotension / hypertension
• Infection • Restenosis of the dilated vessel • Total occlusion of the coronary artery or bypass graft • Unstable angina

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