

FOXTROT PRO

FOXTROT TM PRO
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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