Image of Euphora™ noncompliant balloon dilatation catheter

Image shown may not represent actual product or configuration

NCEUP3012X

Euphora™ Noncompliant Balloon Catheter

The NC Euphora™ rapid exchange balloon dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) rapid exchange system.

Contact a representative

Indications, Safety, and WarningsIndications

The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The balloon dilatation catheter is also indicated for post-deployment expansion of balloon-expandable stents.

Bench testing was conducted with the NC Euphora™ rapid exchange balloon dilatation catheter and commercially available Medtronic balloon expandable stents. Use caution when using this device with different manufacturers’ stents due to difference in stent design.ContraindicationsThe catheter is contraindicated for use in:

Unprotected left main coronary artery

Coronary artery spasm in the absence of significant stenosis

Warnings

For single-patient, single-procedure use only. Do not resterilize or reuse the device. Resterilization or reuse may compromise device performance and increase the risk of inappropriate resterilization and cross-contamination.

Do not use the catheter if its package has been opened or damaged.

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.

Percutaneous transluminal coronary angioplasty (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.

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 as this can potentially result in damage to the vessel wall. If resistance is met during manipulation, determine the cause of the resistance before proceeding.

Balloon pressure should not exceed the rated burst pressure indicated on the package label for each balloon. The rated burst pressure is based on the results of in vitro testing. Use of a pressure monitoring device is recommended to prevent overpressurization.

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.

Use only the recommended balloon inflation medium. To prevent the possibility of an air embolus, never use air or any gaseous medium to inflate the balloon.

Use the catheter prior to the use-by date specified on the package.

Precautions

Prior to angioplasty, examine the catheter to verify functionality and ensure that its size and shape are suitable for the procedure for which it is to be used.

If the device is kinked, it should not be used.

The catheter system should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty.

Administer appropriate anticoagulation, antiplatelet, and vasodilator therapy to the patient.
Note: Testing without anticoagulation shows variable amounts of thrombus formation on the device surface. Thrombogenicity evaluations conducted using a heparinized model do not indicate thrombus formation. If the patient is not appropriately anticoagulated, thrombus formation may occur. Appropriate anticoagulation therapy should be administered to reduce potential thrombosis.

When using two guidewires, use caution when introducing, torquing, and removing one or both guidewires to avoid entanglement. It is recommended that one guidewire be completely withdrawn from the patient before removing any additional equipment.

Do not apply excessive force during preparation or use, as this may damage the device.

The safety and effectiveness of this PTCA balloon catheter for the treatment of instent restenosis (ISR) have not been established.

Adverse effectsPotential adverse effects seen during a PTCA procedure could be associated with this procedure. Possible adverse effects include, but are not limited to:

Death

Acute myocardial infarction

Total occlusion of the coronary artery or bypass graft

Coronary vessel dissection, perforation, rupture, or injury

Restenosis of the dilated vessel

Hemorrhage or hematoma

Unstable angina

Arrhythmias, including ventricular fibrillation

Drug reactions or allergic reaction to contrast medium

Hypotension/hypertension

Infection

Coronary artery spasm

Arteriovenous fistula

Stroke, air embolism, and embolization or fragmentation of thrombotic or athlerosclerotic material

Caution: Federal law (United States) restricts these devices to sale by or on the order of a licensed healthcare practitioner.UC202311556 EN

Not what you're looking for?

Find more information, including other available configurations, for NC Euphora™ noncompliant balloon dilatation catheter.

First Name

Last Name

Hospital Or Organization

Job Role

Specialty

Confirm country/region

Just to confirm, is this the product or product type that interests you?

{{productNamePlaceholder}}

This is intended for non-urgent inquiries only.
If you have a medical emergency, call 911 immediately.
If you have medical questions, contact your doctor.

Confirm country/region

Before we get started, what best describes you?

This is intended for non-urgent inquiries only.
If you have a medical emergency, call 911 immediately.
If you have medical questions, contact your doctor.

Confirm country/region

Before we get started, what best describes you?

First Name

Last Name

Hospital Or Organization

HOSPITAL POSTAL CODE

Job Role

Specialty

First Name

Last Name

PHONE

Hospital Or Organization

HOSPITAL POSTAL CODE

Job Role

Specialty

First Name

Last Name

PHONE

Hospital Or Organization

COUNTRY

HOSPITAL POSTAL CODE

Job Role

Specialty

First Name

Last Name

Hospital Or Organization

Country

HOSPITAL POSTAL CODE

Job Role

Specialty

First Name

Last Name

Title

STATE / PROVINCE

PHONE

Hospital Or Practice

Job Role

Specialty

{{productNamePlaceholder}} New products & technology New services Education & training Clinical information Customer Experience Surveys

If you subscribe to email updates, you can unsubscribe anytime via the link in each email. We use technology to measure email opens and clicks, to improve our communications and provide relevant content. For details, see our {link}

I have read and agree with the terms and conditions.

First Name

Last Name

Title

STATE / PROVINCE

PHONE

Hospital Or Practice

Job Role

Specialty

{{productNamePlaceholder}} New products and technology New services Education and training Clinical information Customer experience surveys

I have read and agree with the terms and conditions.

Your personal data will be used to manage your relationship with Medtronic in accordance with our {link}

NCEUP3012X Euphora™ Noncompliant Balloon Catheter

Not what you're looking for?

United States

Customer Care Team

NCEUP3012X

Euphora™ Noncompliant Balloon Catheter