Cook Medical now offers physicians an innovative technology to help treat peripheral arterial disease (PAD) from the knee all the way to the digital arteries. The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter features a balloon diameter as small as just 1.5 mm and creates new options for treating PAD.
The following animation shows how a physician can continue an infrapopliteal procedure via a retrograde tibiopedal approach after a failed ante grade approach.
The products that appear in the animation include the Advance Micro 14 balloon, the CXI® Support Catheter, the Micropuncture® Pedal Introducer Access Set, and the Approach® Hydro ST Microwire Guide. Click a product link to view its catalog listing.
Essential prescribing information
ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
Intended use
Used for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including internal pudendal, iliac, renal, popliteal, femoral, iliofemoral, anterior tibial, posterior tibial, peroneal, pedal, radial, brachial, and ulnar, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary arteries.
Warnings
Do not exceed rated burst pressure.1 Rupture of balloon may occur. Adhere to balloon inflation pressure parameters in the compliance card insert. Overinflation 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.
Precautions
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. The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter has been designed for introduction into the vascular system utilising percutaneous (Seldinger) technique. 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.
1 The burst pressure data was analysed using factors for a one-sided tolerance to determine with 95% confidence that 99.9% of these balloons would not burst below the calculated rated burst pressure.
CXI SUPPORT CATHETER
Intended use
Used in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
Warnings
Maximum recommended infusion pressure is 1,200 psi. Avoid introducing air or any other gas through the catheter into the vascular system.
Precautions
This product is intended for use by physicians trained and experienced in small vessel access and interventional procedures. Standard techniques for placement of percutaneous catheters should be employed. Catheter manipulation should only occur under fluoroscopy. If the catheter is used for infusion, reference the table of flow rates in the device description section of the Instructions for Use and ensure infusion pressure does not exceed the recommendations. The catheter should not be advanced into a vessel having a reference vessel diameter smaller than the catheter outer diameter. This catheter is designed and intended for one time use only. Do not resterilise and/or reuse. The catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction. This catheter should only be used by physicians qualified to perform percutaneous vascular interventions.
APPROACH HYDRO ST MICROWIRE GUIDE
Intended use
Used to facilitate delivery of percutaneous catheters into the peripheral vasculature.
Warnings
This wire guide is a delicate instrument and should be handled carefully; forceful angulation should be avoided. The wire guide should be advanced only when visualising the tip of the wire guide fluoroscopically. The wire guide should not be torqued without evidence of corresponding movement of the distal tip. Refer to the labeling of the percutaneous catheter or other therapeutic devices for contraindications and potential complications associated with use. Approach Hydro ST wire guides should never be used in conjunction with or through a metal needle cannula.
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. Avoid manipulating or withdrawing the wire guide back through a metal needle or cannula. A sharp edge may scrape the coating or shear the wire guide. A catheter, introducer sheath or vessel dilator should replace the needle as soon as the wire guide has been inserted in the vessel. Excessive tightening of the torque device (if provided) onto the wire guide may result in abrasion of the coating on the wire. Always flush the Hydro ST before use. Always maintain a wet surface on the hydrophilic portion of the Hydro ST for optimal results.