The MOZEC™ Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion ofa coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The MOZEC™ Rx PTCA Balloon Dilatation Catheter (balloon models 2.25nun to 4.50nun) is also indicated for post-delivery expansion of balloon expandable stents.
Note: Bench testing was conducted with the MOZEC™ Rx PTCA Balloon Dilatation Catheter and marketed balloon expandable stents (viz. Medtronic Integrity andAbbott's Multi Link Stents). Consideration should be taken when this device is used with different manufacturer's stents due to differences in stent design. All stents should be deployed in accordance with the manufacturer'sindications and instructions for use.
Unprotected left main coronary artery lesion. Coronary artery spasm in the absence of a significant stenosis. Patients with a contraindication for anti-platelet/anticoagulant therapy.
- For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure which, in tum, may result in patient injury, illness or death.
- Reuse, reprocessing orre-sterilization may also create a risk of contamination of the device and/ or cause patient infection or cross-infection, including, but not limited to the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
- PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication.
- Since use of this device carries the associated risk of sub-acute thrombosis, vascular complications and/or bleeding events, judicious selection of patients is necessary.
Note: Animal testing in canines showed thrombus formation along the catheter length when anticoagulation was not used.
- PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including potential haemodynamic support during the procedure, as treatment of this patient population carries special risk.
- Guiding catheters used must have lumen sizes that are suitable to acconunodate the introduction of MOZEC™ Rx PTCA Balloon Dilatation Catheter.
- Do not use if the inner package is open or damaged. Carefully remove the PTCA catheter from the pouch to prevent damage and premature removal of the balloon cover.
- To reduce the potential for air embolus into the vessel, use only the reconunended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.
- When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is felt during manipulation, determine the cause of the resistance before proceeding.
- Balloon pressure should not exceed the rated burst pressure. The rated burst pressure is based on the results of in vitro testing. At least 99.9 percent of the balloons, (with a 95 percent confidence) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is reconunended to prevent over pressurization.
- To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.
- Prior to angioplasty, examine the PTCA catheter to verify functionality. Ensure that its size and shape are suitable for the specific procedure for which it is to be used.
- Only the physicians trained in the performance of PTCA should use the catheter system. Appropriate anticoagulant/antiplatelet and vasodilator therapy should be used during the procedure.
- Prior to reinsertion or withdrawal of the PTCA catheter, wipe the guide wire with saline-soaked gauze to remove blood or other residues.
- After the procedure, anticoagulant therapy should be continued as reconunended by the physician. Use the catheter before the "Use by" date specified on the package.
Potential adverse events, which may be associated with the use of the MOZEC™ Rx PTCA Balloon Dilatation Catheter, include but are not limited to:
- Acute myocardial infarction Acute vessel closure
- Allergic reactions to anti-coagulant and /or antithrombotic therapy/ contrast medium Arrhythmia, including ventricular fibrillation (VF)
- Arteriovenous fistula Coronary embolism Coronary artery spasm Coronary aneurysm
- Coronary vessel dissection/injury/perforation/rupture Death
- Emergency or non-emergent Coronary Artery Bypass Graft Surgery Hematoma or Hemorrhage
- Hypotension I Hypertension
- Infection and / or pain at the access site Restenosis of treated segment
- Total occlusion of coronary artery/bypass graft Unstable angina pectoris
- Stroke, air embolism and embolization or fragmentation of thrombotic or atherosclerotic material