MOZEC™ NC Rx PTCA Balloon Dilatation Catheter

Combines controlled balloon growth with the longest lengths on the U.S. market.

Product Description

The MOZEC™ NC PTCA Balloon combines flat compliance at high pressure with the longest lengths on the U.S. market.

  • Designed to deliver in the most challenging cases 
  • Balloon sizes from 2.25-4.50mm in diameter and 8-35mm in length – the longest balloons on the U.S. market 
  • Features Nylon noncompliant balloon material 
  • Nominal pressure 12atm 
  • Rated burst pressure 20atm

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
2.25 mm 8 mm 20 atm MNC22508
2.25 mm 10 mm 20 atm MNC22510
2.25 mm 13 mm 20 atm MNC22513
2.25 mm 15 mm 20 atm MNC22515
2.25 mm 18 mm 20 atm MNC22518
2.25 mm 23 mm 20 atm MNC22523
2.25 mm 28 mm 20 atm MNC22528
2.25 mm 35 mm 20 atm MNC22535
2.50 mm 8 mm 20 atm MNC25008
2.50 mm 10 mm 20 atm MNC25010
2.50 mm 13 mm 20 atm MNC25013
2.50 mm 15 mm 20 atm MNC25015
2.50 mm  18 mm 20 atm MNC25018
2.50 mm 23 mm 20 atm MNC25023
2.50 mm 28 mm 20 atm MNC25028
2.50 mm 35 mm 20 atm MNC25035
2.75 mm 8 mm 20 atm MNC27508
2.75 mm 10 mm 20 atm MNC27510
2.75 mm 13 mm 20 atm MNC27513
2.75 mm 15 mm 20 atm MNC27515
2.75 mm 18 mm 20 atm MNC27518
2.75 mm 23 mm 20 atm MNC27523
2.75 mm 28 mm 20 atm MNC27528
2.75 mm 35 mm 20 atm MNC27535
3.00 mm 8 mm  20 atm MNC30008
3.00 mm 10 mm 20 atm MNC30010
3.00 mm 13 mm 20 atm MNC30013
3.00 mm 15 mm 20 atm MNC30015
3.00 mm 18 mm 20 atm MNC30018
3.00 mm 23 mm 20 atm MNC30023
3.00 mm 28 mm 20 atm MNC30028
3.00 mm 35 mm 20 atm MNC30035
3.50 mm 8 mm 20 atm MNC35008
3.50 mm 10 mm 20 atm MNC35010
3.50 mm 13 mm 20 atm MNC35013
3.50 mm 15 mm 20 atm MNC35015
3.50 mm 18 mm 20 atm MNC35018
3.50 mm 23 mm 20 atm MNC35023
3.50 mm 28 mm 20 atm MNC35028
3.50 mm 35 mm 20 atm MNC35035
4.00 mm 8 mm 20 atm MNC40008
4.00 mm 10 mm 20 atm MNC40010
4.00 mm 13 mm 20 atm MNC40013
4.00 mm 15 mm 20 atm MNC40015
4.00 mm 18 mm 20 atm MNC40018
4.00 mm 23 mm 20 atm MNC40023
4.00 mm 28 mm 20 atm MNC40028
4.00 mm 35 mm 20 atm MNC40035
4.50 mm 8 mm 20 atm MNC45008
4.50 mm 10 mm 20 atm MNC45010
4.50 mm 13 mm 20 atm MNC45013
4.50 mm 15 mm 20 atm MNC45015
4.50 mm 18 mm 20 atm MNC45018
4.50 mm 23 mm 20 atm MNC45023
4.50 mm 28 mm 20 atm MNC45028
4.50 mm 35 mm 20 atm MNC45035

 

 

 

IFU

Indications
The MOZEC™ NC Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The MOZEC ™ NC Rx PTCA Balloon Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.

Note: Bench testing was conducted with the MOZEC™ NC Rx PTCA Balloon Dilatation Catheter and marketed balloon expandable stents (viz. Medtronic Integrity, Boston Scientifics Liberte & Abbott’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’s indications and instructions for use.

Contraindications

  • Unprotected left main coronary artery lesion. 
  • Coronary artery spasm in the absence of a significant stenosis. 

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 turn, may result in patient injury, illness or death. 
  • Reuse, reprocessing or re-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. 
  • 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 accommodate the introduction of MOZECTM NC 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 recommended 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 recommended 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. 
  • The safety and effectiveness of this PTCA balloon catheter for the treatment of ISR has not been established. 
  • 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 recommended 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™ NC - 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 / 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