INTENDED USE

The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended 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. Not for use in the cerebral or coronary vasculature.

CONTRAINDICATIONS

None known

WARNINGS

• Do not exceed rated burst pressure.1 Rupture of balloon may occur. Adhere to balloon inflation pressure parameters in the Compliance Card insert.

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

• This 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.

• This device 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 the 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 expiration 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.

• 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