Charger™ 0.035” Balloon Dilatation Catheter

Overview

The Charger Balloon is designed to deliver results in both routine and challenging cases.

Product Details

Charger is the 0.035” balloon you can count on

Boston Scientific’s Charger is a steadfast 0.035” Balloon Dilatation Catheter designed to deliver results in both routine and challenging cases. It offers excellent push and track, a low profile, rapid deflation, non-compliant dilatation, and a full range of sizes.

Post-Stent Dilatation

  • Non-compliant for excellent stent-to-wall apposition
  • Higher pressure when needed (up to 20 atm for 5x200 mm)

High pressure, non-compliant chart
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Low Profile

  • 0.040” tip over a 0.035” wire
  • 6x150 and 7x80 through 5Fr
  • 10x80 through 6Fr
  • Excellent rewrap

    • Low profile chart
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      Broad Size Matrix

      • Balloon lengths 20-200 mm
      • Diameters 3-12 mm
      • Shafts 75, 135 cm

      Full size matrix chart
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      Charger 0.035 Balloon Dilatation Catheter Schematic>
      Click to enlarge


      The C-code used for this product is C1725, Catheter, transluminal angioplasty, non-laser. C-codes are used for hospital outpatient device reporting for Medicare and some private payers.

      Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice.

      PI-34217-AA OCT2011

      Prescriptive Information

      Contraindications

      None known.

      Warnings

      The Charger PTA balloon catheter is not for use in the coronary arteries. Any use for procedures other than those indicated in these instructions is not recommended.

      Prescriptive Information

      Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.




      Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.


      Intended Use/Indications for Use

      The Charger Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Charger Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. Charger Balloon Dilatation Catheters with balloons up to 120 mm in length are indicated for the treatment of biliary strictures.

      Precautions

      The Charger PTA Balloon Dilatation Catheter shall only be used by physicians trained in the performance of percutaneous transluminal angioplasty. The Charger PTA Balloon Dilatation Catheter should be used with caution for procedures involving calcified lesions or synthetic vascular grafts due to the abrasive nature of these inflation sites.

      Adverse Events

      The complications that may result from a balloon dilatation procedure include, but are not limited to:
      • Allergic reaction (device, contrast medium and medications)
      • Arteriovenous fistula
      • Embolization (air, device, plaque, etc.)
      • Hematoma
      • Hemorrhage, including bleeding at puncture site
      • Pseudoaneurysm
      • Sepsis/infection
      • Thromboembolic episodes
      • Vessel injury, e.g. dissection, perforation, rupture
      • Vessel occlusion
      • Vessel spasm.


      Additionally, the following complications may result from a balloon dilatation procedure within the biliary system:
      • Cholangitis
      • Hemobilia
      • Pancreatitis
      • Duct injury, e.g. dissection, perforation, rupture
      • Duct occlusion
      • Duct spasm.

      Product Callouts

      Directions for Use

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