Athletis™ PTA Balloon Catheter

Indications, Safety and Warnings


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 “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions


INTENDED USE/INDICATIONS FOR USE

The Athletis PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature including upper extremity, renal, iliac, and infrainguinal vessels and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Athletis PTA Balloon Dilatation Catheter is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature.

CONTRAINDICATIONS

None known.
 

WARNINGS

The Athletis PTA Balloon Dilatation Catheter is not for use in the coronary arteries. Any use  for procedures other than those indicated in these instructions is not recommended.
 

PRECAUTIONS

The Athletis™ PTA Balloon Dilatation Catheters are not intended for injection of contrast medium.To prevent over pressurization, use of a pressure monitoring device is recommended.
Precautions to prevent or reduce clotting should be taken when any catheter is used:

  • Consider systemic anticoagulation.
  • Flush or rinse all products with sterile 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 or other)
  • Arrhythmia
  • Arteriovenous fistula
  • Cerebral Vascular Accident (CVA) / stroke / Transient Ischemic Attack (TIA)
  • Death
  • Embolization (air, device, plaque, thrombus or other)
  • Hematoma
  • Hemorrhage
  • Hypotension/hypertension
  • Ischemia
  • Myocardial Infarction/ischemia
  • Need for urgent intervention or surgery
  • Pain
  • Pulmonary Embolism
  • Renal Insufficiency or failure
  • Restenosis
  • Sepsis/infection
  • Thrombosis/thrombus
  • Vasospasm
  • Vessel injury (e.g. dissection, perforation, rupture, pseudoaneurysm, trauma, or other)
  • Vessel occlusion
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