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Indications, Safety and Warnings

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Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Sterling PTA Balloon Dilatation Catheter

INTENDED USE/INDICATIONS FOR USE

The Sterling PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These devices are also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. The Sterling Monorail PTA Balloon Dilatation Catheter (only) is also indicated for the carotid arteries.

CONTRAINDICATIONS

None Known.

GENERAL PRECAUTIONS

The Sterling 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 lesions.

The Sterling PTA Balloon Dilatation Catheters are not intended for injection of contrast medium.

The Sterling™ PTA Balloon Dilatation Catheter shall only be used by physicians trained in the performance of percutaneous transluminal angioplasty.

Precautions to prevent or reduce clotting should be taken when any catheter is used:

  • Consider systemic heparinization.
  • Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution prior to use.

ADVERSE EVENTS

The complications that may result from a balloon dilatation procedure include, but are not limited to:

  • Allergic reaction to contrast medium
  • Arrhythmias
  • Arteriovenous fistula
  • Cerebrovascular accidents (specific to MR)
  • Death
  • Hematoma
  • Hemodynamic instability
  • Hemorrhage
  • Pseudoaneurysm
  • Pyrogenic reaction
  • Sepsis/infection
  • Thromboembolic episodes
  • Vascular thrombosis
  • Vessel injury, e.g. dissection, perforation, rupture
  • Vessel occlusion
  • Vessel spasm
PI-343047-AA SEP2015

Sterling SL PTA Balloon Dilatation Catheter

INTENDED USE/INDICATIONS FOR USE

The Sterling SL  PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

CONTRAINDICATIONS

None Known.

GENERAL PRECAUTIONS

  • The Sterling SL PTA Balloon Dilatation Catheter shall only be used by physicians trained in the performance of percutaneous transluminal angioplasty.
  • The Sterling SL 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 lesions. The Sterling SL PTA Balloon Dilatation Catheters are not intended for injection of contrast medium. Precautions to prevent or reduce clotting should be taken when any catheter is used:
  • Consider systemic heparinization.
  • Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution prior to use.

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
PI-343048-AA SEP2015

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