MOZEC™ Rx PTCA Balloon Dilatation Catheter

The MOZEC™ Rx PTCA Balloon Dilatation Catheter, now available from Cordis, combines the competitive features of an ideal workhorse balloon dilatation catheter.

Product Description

The MOZEC™ Rx PTCA Balloon Dilatation Catheter, now available from Cordis, combines the competitive features of an ideal workhorse balloon dilatation catheter.

  • Balloon sizes from 1.50-4.50mm in diameter and 9-41mm in length – the longest balloons on the market 
  • Features MeriGlide™ hydrophilic coating from distal balloon neck up to Rx port for smooth navigation 
  • Elongated 5mm tip for 1.50 and 2.00mm balloons for distal stability and gudiewire support 
  • Nominal pressure 7atm 
  • Rated burst pressure 14-16atm

Clinical Resources

  • Brochure
  • Sell Sheet

Ordering Information

In the United States, fax your order to 877.933.0133, email GMB-ACI-Customer-Service@cardinalhealth.com, or call 877.700.6969.

 

Balloon Diameter Balloon Length Rated Burst Pressure Product Code
1.50 mm 9 mm 16 atm MOZ15009
1.50 mm 12 mm 16 atm MOZ15012
1.50 mm 15 mm 16 atm MOZ15015
2.0 mm 9 mm 16 atm MOZ20009
2.0 mm 12 mm 16 atm MOZ20012
2.0 mm 15 mm 16 atm MOZ20015
2.25 mm 9 mm 16 atm MOZ22509
2.25 mm 14 mm 16 atm MOZ22514
2.25 mm 17 mm 16 atm MOZ22517
2.25 mm 20 mm 16 atm MOZ22520
2.50 mm 9 mm 16 atm MOZ25009
2.50 mm 14 mm 16 atm MOZ25014
2.50 mm 17 mm 16 atm MOZ25017
2.50 mm 20 mm 16 atm MOZ25020
2.50 mm 25 mm 16 atm MOZ25025
2.50 mm 30 mm 16 atm MOZ2530
2.50 mm 41 mm 16 atm MOZ25041
2.75 mm 9 mm 16 atm MOZ27509
2.75 mm 14 mm 16 atm MOZ27514
2.75 mm 17 mm 16 atm MOZ27517
2.75 mm 20 mm 16 atm MOZ27520
3.0 mm 9 mm 16 atm MOZ30009
3.0 mm 14 mm 16 atm MOZ30014
3.0 mm 17 mm 16 atm MOZ30017
3.0 mm 20 mm 16 atm MOZ30020
3.0 mm 25 mm 16 atm MOZ30025
3.0 mm 30 mm 16 atm MOZ30030
3.0 mm 38 mm 16 atm MOZ30038
3.0 mm 41 mm 16 atm MOZ30041
3.50 mm 9 mm 16 atm MOZ35009
3.50 mm  14 mm 16 atm MOZ35014
3.50 mm 17 mm 16 atm MOZ35017
3.50 mm 20 mm 16 atm MOZ25020
3.50 mm 25 mm 16 atm MOZ35025
3.50 mm 30 mm 16 atm MOZ35030
3.50 mm 38 mm 16 atm MOZ35038
4.0 mm 9 mm 16 atm MOZ40009
4.0 mm 14 mm 16 atm MOZ40014
4.0 mm 17 mm 16 atm MOZ40017
4.0 mm 20 mm 16 atm MOZ40020
4.0 mm 30 mm 16 atm MOZ40030
4.50 mm 9 mm 14 atm MOZ45009
4.50 mm 14 mm 14 atm MOZ45014
4.50 mm 17 mm 14 atm MOZ45017
4.50 mm 20 mm 14 atm  MOZ45020

IFU

Indications

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.

Contraindications
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.

Warnings

  • 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. 

Precautions

  • 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. 

Adverse Effects:
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