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.