MOZEC PTA 35
Mozec PTA is a percutaneous transluminal angioplasty balloon catheter system for treatment of vessels with obstructive disease, sub-total or total occluded peripheral vessel.
Low tip entry profile aides Crossability through tight lesions
BioGlide™ hydrophilic coating on balloon and shaft provides enhanced Deliverability
Superior force transmission with seamless single tube transition provides FeatherLite™ Pushability
FeatherGlide™ Trackability with low tracking force
Fatigue Resistance balloon material provides better Durability
- SMALLER DIAMETER BALLOON (3 MM) ON 0.035
- TREAT LONG DIFFUSED SFA LESIONS WITH 300 MM LONG BALLOON
- EXPERIENCE ENHANCED NAVIGATION
Benefits
Assured Trackability + Superior Deliverability + Responsive Pushability = Enhanced Navigation
Extend your reach of treatment with longer length balloons upto 300 mm
3/6 fold good rewrap profile helpful during multiple dilatation
Faster Inflation / Deflation Time (*<10 sec) reduces radiation exposure time
Semi Compliant PEBA balloon material provides better balloon flexibility
Indication
The Mozec™ PTA OTW 0.035” Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Product Specifications
| Catheter System | Over-The-Wire (OTW) |
| Balloon Material | PEBA |
| Catheter Usable Length | 80±2cm & 135 ± 2 cm |
| Max Guidewire Compatibility | 0.035" |
| Min Sheath Comptibility | 5F / 6F / 7F Depending upon diameter and length of balloon (Refer labels for details) |
| Shaft/Balloon Coating | Biocompatible Hydrophilic Lubricious coating on Balloon + Distal Shaft |
| Tip Length | 5.0 ± 1 mm |
| Balloon RO Markers | 2 Platinum-Iridium |
| Shaft Diameter |
5.0F (1.72±0.025mm) for balloon dia. 3 to 10mm 6.0F (1.98±0.025mm) for balloon dia. 12 to 14mm |
| Nominal Pressure (NP) | 6 - 7 ATM depending upon diameter and length of balloon (Refer labels for more details) |
| Rated Burst Pressure (RBP) | 11 - 14 ATM depending upon diameter and length of balloon (Refer labels for more details) |
Size Chart
| Guidewire Comptibility 0.035": Usable Shaft Length (OTW) - 80 cm | |||||||||||
| Diameter/Length (mm) | |||||||||||
| 20mm | 30mm | 40mm | 50mm | 60mm | 80mm | 120mm | 150mm | 200mm | 250mm | 300mm | |
| 3.00 | MO35030020A | MO35030030A | MO35030040A | MO35030050A | MO35030060A | MO35030080A | MO35030120A | MO35030150A | MO35030200A | MO35030250A | MO35030300A |
| 4.00 | MO35040020A | MO35040030A | MO35040040A | MO35040050A | MO35040060A | MO35040080A | MO35040120A | MO35040150A | MO35040200A | MO35040250A | MO35040300A |
| 5.00 | MO35050020A | MO35050030A | MO35050040A | MO35050050A | MO35050060A | MO35050080A | MO35050120A | MO35050150A | MO35050200A | MO35050250A | MO35050300A |
| 6.00 | MO35060020A | MO35060030A | MO35060040A | MO35060050A | MO35060060A | MO35060080A | MO35060120A | MO35060150A | MO35060200A | MO35060250A | MO35060300A |
| 7.00 | MO35070020A | MO35070030A | MO35070040A | MO35070050A | MO35070060A | MO35070080A | MO35070120A | MO35070150A | - | - | - |
| 8.00 | MO35080020A | MO35080030A | MO35080040A | MO35080050A | MO35080060A | MO35080080A | MO35080120A | MO35080150A | - | - | - |
| 9.00 | MO35090020A | MO35090030A | MO35090040A | MO35090050A | MO35090060A | MO35090080A | - | - | - | - | - |
| 10.00 | MO350100020A | MO350100030A | MO350100040A | MO350100050A | MO350100060A | MO350100080A | - | - | - | - | - |
| 12.00 | MO350120020A | MO350120030A | MO350120040A | MO350120050A | MO350120060A | MO350120080A | - | - | - | - | - |
| 14.00 | M0350140020A | MO350140030A | MO350140040A | MO350140050A | MO350140060A | MO350140080A | - | - | - | - | - |
| Guidewire Compatibility: 0.035": Usable Shaft Length (OTW) - 135 cm | |||||||||||
| Diameter/Length (mm) | |||||||||||
| 20mm | 30mm | 40mm | 50mm | 60mm | 80mm | 120mm | 150mm | 200mm | 250mm | 300mm | |
| 3.00 | MO35030020A | MO35030030A | MO35030040A | MO35030050A | MO35030060A | MO35030080A | MO35030120A | MO35030150A | MO35030200A | MO35030250A | MO35030300A |
| 4.00 | MO35040020A | MO35040030A | MO35040040A | MO35040050A | MO35040060A | MO35040080A | MO35040120A | MO35040150A | MO35040200A | MO35040250A | MO35040300A |
| 5.00 | MO35050020A | MO35050030A | MO35050040A | MO35050050A | MO35050060A | MO35050080A | MO35050120A | MO35050150A | MO35050200A | MO35050250A | MO35050300A |
| 6.00 | MO35060020A | MO35060030A | MO35060040A | MO35060050A | MO35060060A | MO35060080A | MO35060120A | MO35060150A | MO35060200A | MO35060250A | MO35060300A |
| 7.00 | MO35070020A | MO35070030A | MO35070040A | MO35070050A | MO35070060A | MO35070080A | MO35070120A | MO35070150A | - | - | - |
| 8.00 | MO35080020A | MO35080030A | MO35080040A | MO35080050A | MO35080060A | MO35080080A | MO35080120A | MO35080150A | - | - | - |
| 9.00 | MO35090020A | MO35090030A | MO35090040A | MO35090050A | MO35090060A | MO35090080A | - | - | - | - | - |
| 10.00 | MO350100020A | MO350100030A | MO350100040A | MO350100050A | MO350100060A | MO350100080A | - | - | - | - | - |
| 12.00 | MO350120020A | MO350120030A | MO350120040A | MO350120050A | MO350120060A | MO350120080A | - | - | - | - | - |
| 14.00 | MO350140020A | MO350140030A | MO350140040A | MO350140050A | MO350140060A | MO350140080A | - | - | - | - | - |
Clinical Data
Product IFU
Note: IFU will be displayed after MDR Certification