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