Vanguard IEP® System

Indications, Safety, & Warnings

The Vanguard System is cleared for sale in the USA. Caution: Federal (or United States) law restricts this device to sale by or on the order of a physician.

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Indications for Use

The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries. The System is not intended for use in the renal, cerebral, coronary or carotid vasculature.

Contraindications

    • Contraindicated for use in patients with known hypersensitivity to nickel or titanium.
    • Contraindicated for use in patients who cannot tolerate anticoagulant or anti-platelet therapy.
    • Contraindicated for use in patients with unresolved bleeding disorders.

Warnings

    • The use of this product carries the risks associated with peripheral vascular angioplasty, including thrombosis, vascular complications, and/or bleeding events.
    • Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with peripheral interventional procedures should use this device.
    • The inner package should not be opened or damaged prior to use to maintain sterility.
    • The device is intended for one use only. Do not re-insert the Vanguard IEP System after it has been removed from the patient.
    • Do not re-sterilize or reuse, as this can result in compromised device performance.
    • Do not deploy the integrated filter within a stent.
    • Only use a Tuohy-Borst Adaptor that can be opened by rotating the proximal Luer.
    • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Precautions

    • The Vanguard IEP System is provided STERILE for SINGLE USE ONLY.
    • Use the Vanguard IEP System catheter prior to the expiration date printed on the package.
    • Do not use the Vanguard IEP System if the sterile package is compromised or if the device is damaged.
    • The outer box is not a sterile barrier. The pouch contained within the outer box is the sterile barrier. Only the contents of the inner pouch are sterile. The outside surface of the inner pouch is not sterile. Do not remove the contents of pouch until immediately prior to the use of device.
    • Before angioplasty, the catheter should be examined to verify functionality and ensure that its labeled size and shape are suitable for the procedure for which it is to be used.
    • Before insertion of the Vanguard IEP System, administer the appropriate anti-coagulant therapy approved in your institution for this procedure.
    • It is recommended to thoroughly wipe the guidewire clean with heparinized saline for better device catheter movement on the wire during the loading or exchanging of the device catheter.
    • Vascular procedures should only be performed by physicians who have received appropriate training.
    • Use only the appropriate balloon inflation media. Do not use air or any gaseous medium to inflate the balloon.
    • Risks and benefits should be considered in patients with severe contrast agent allergies.
    • Before withdrawing the delivery system, visually confirm complete balloon deflation and filter collapse by fluoroscopy to avoid arterial damage.
    • Use caution when passing the device through a previously deployed stent.
    • Do not expose or wipe the product with organic solvents such as alcohol or detergents.
    • Should any unusual resistance be felt, gently advance the catheter, rotate, and then withdraw again.
    • If it is necessary to retain guidewire position for subsequent artery/lesion access, leave the guidewire in place and remove all other system components.

Adverse Effects

Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to the following:

    • Abrupt vessel thrombosis or occlusion
    • Aneurysm, pseudoaneurysm
    • Arrhythmias
    • Arteriovenous fistula
    • Vascular access site injuries including bleeding, hemorrhage or hematoma
    • Injury to the artery of different degrees, including dissection and perforation
    • Death
    • Embolization
    • Complications related to concomitant medications (drug reactions, bleeding from antiplatelet/anti-coagulation agents, allergic reactions to the contrast medium)
    • Hypotension/hypertension
    • Infection or fever
    • Ischemia
    • Renal failure
    • Spasm