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FOXTROT PRO ( PTCA Balloon Catheter )
Reg.No: KEMENKES RI AKL 20501610542

FOXTROT TM PRO PTCA Balloon Catheter is a semi-compliant Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System, that consists of an integrated shaft and a balloon at the distal end of the catheter. The proximal end of the catheter has a standard luer to inflate or deflate the balloon by contrast medium. The balloon catheter is coated with hydrophilic coating.

Indication :

FOXTROT TM PRO is indicated for ballon pre-dilatation of the stenotic atherosclerotic lesions in patients with following coronary artery diseases :

  • Angina pectoris (stable or unstable)
  • Myocardial infarction (acute or chronic)
  • One or more stenosis in one vessel
  • Multi-vessel stenosis and distal vessel stenosis
  • Coronary artery re-stenosis after coronary artery bypass graft (CABG)
  • Coronary artery re-stenosis after PTCA
  • Protected left main coronary artery stenosis

Contraindications :

FOXTROT TM PRO is not intended to be used to treat patients with :

  • Unprotected left main coronary artery stenosis
  • Coronary stenosis < 50%
  • Serious multi-vessel calcified lesions, diffuse atherosclerotic lesions
  • Chronic total occlusion lesions (relative contraindication)

Potential Adverse Effects :

Potential adverse effects include, but are not limited to :

  • Coronary artery lesion, even perforation of the artery wall
  • Acute coronary artery occlusion and acute myocardial infarction
  • Arrhythmias
  • Unstable angina pectoris
  • Re-stenosis of the dilated artery
  • Coronary artery spasm
  • Local hematoma and obstruction in the femoral artery puncture site;
  • Hemorrhage;
  • Death
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