Z-MED™(US)
Percutaneous Transluminal Valvuloplasty (USA)
Z-MED™(US)
Z-MED™ high pressure balloon catheters were designed in collaboration with Dr. Ziyad Hijazi. The Z-MED™ catheters are suitable for percutaneous transluminal valvuloplasty (PTV) and pre-dilatation in transcatheter heart-valve replacement procedures. They feature high rated burst pressures suitable for resistant stenosis and have rapid inflation and deflation times to minimize procedure time and maximize reperfusion.
Short, flexible distal tips with short balloon tapers aid maneuverability and trackability through tortuous anatomy. They are available in a wide range of balloon diameters (2.0-40.0mm) and lengths (2.0-10cm).
Z-MED™ catheters are available in the US through B. Braun Interventional Systems, Inc.
Unique Benefits
Z-MED™ PTV balloons are coaxially constructed with a non-compliant high pressure balloon suitable for resistant stenosis. The Z-MED™ balloons have extremely fast inflation and deflation times for a quick procedure. The low profile of the Z-MED™ requires a small introducer for a high pressure balloon. The distal shaft through the balloon is highly flexible for maximum trackability. This, combined with the pushability of the coaxial shaft, provides outstanding tracking performance.
The catheter bodies are Polymeric, DEHP-free, and not made with natural rubber latex. The balloons are a thermoplastic elastomer; non-compliant - which will not exceed +/- 10% of the labeled balloon size at RBP or NBP, are DEHP-free, and not made with natural rubber latex.
Z-MED™: Specifications and Instructions for Use
Balloon Diameters (mm): 2.0-40.0
Balloon Lengths (cm): 2.0-8.0
Rated Burst Pressure (ATM): 1-10
Introducer Size (FR): 6-16
Indication: PTV of the Pulmonary Valve and Aortic Valve
Z-MED IFU:
US: IFU-302BV
Z-MED II™: Specifications and Instructions for Use
Z-MED II™ catheters have higher rated burst pressures than Z-MED™ and Z-MED-X™.
Balloon Diameters (mm): 4.0-30.0
Balloon Lengths (cm): 2.0-10.0
Rated Burst Pressure (ATM): 3-15
Introducer Size (FR): 5-16
Indication: PTV of the Pulmonary Valve and Aortic Valve
Z-MED II™ IFU:
US: IFU-305BV
Z-MED-X™: Specifications and Instructions for Use
Z-MED-X™ catheters have a radiopaque braided inner tubing for extra high inner lumen strength and increased pushability.
Balloon Diameters (mm): 8.0-30.0
Balloon Lengths (cm): 2.0-6.0
Rated Burst Pressure (ATM): 2-10
Introducer Size (FR): 7-13
Indication: PTV of the Pulmonary Valve
Z-MED-X™ IFU:
US: IFU-302XB
Z-MED II-X™: Specifications and Instructions for Use
Z-MED II-X™ catheters have higher rated burst pressures than Z-MED™ and Z-MED-X™, and a radiopaque braided inner tubing for extra high inner lumen strength and increased pushability.
Balloon Diameters (mm): 8.0-30.0
Balloon Lengths (cm): 2.0-6.0
Rated Burst Pressure (ATM): 3-15
Introducer Size (FR): 7-16
Indication: PTV of the Pulmonary Valve
Z-MED II-X™ IFU:
US: IFU-305XB
| Balloon Diameter (mm) | Balloon Length (cm) | Introducer (FR) | Shaft Size (FR) | Usable Length (cm) | Guide Wire (inches) | Rated Burst Pressure (ATM) | Maximum Volume (cc) | Catalog Number | Product |
|---|---|---|---|---|---|---|---|---|---|
| 14.0 | 4.00 | 7 | 6.0 | 100 | 0.035 | 6.0 | PDZ380 | Z-MED | |
| 14.0 | 4.00 | 8 | 7.0 | 100 | 0.035 | 6.0 | PDZ421 | Z-MED-X | |
| 14.0 | 4.00 | 9 | 7.0 | 100 | 0.035 | 6.0 | PDZ334 | Z-MED | |
| 14.0 | 4.00 | 9 | 7.0 | 100 | 0.035 | 10.0 | PDZ641 | Z-MED II | |
| 14.0 | 4.00 | 9 | 7.0 | 100 | 0.035 | 10.0 | PDZ721 | Z-MED II-X | |
| 14.0 | 4.00 | 9 | 8.0 | 100 | 0.035 | 6.0 | PDZ369 | Z-MED | |
| 14.0 | 5.00 | 8 | 7.0 | 100 | 0.035 | 6.0 | PDZ422 | Z-MED-X | |
| 14.0 | 5.00 | 9 | 7.0 | 100 | 0.035 | 6.0 | PDZ351 | Z-MED | |
| 14.0 | 5.00 | 9 | 7.0 | 100 | 0.035 | 10.0 | PDZ642 | Z-MED II | |
| 14.0 | 5.00 | 9 | 7.0 | 100 | 0.035 | 10.0 | PDZ722 | Z-MED II-X | |
| 14.0 | 6.00 | 8 | 7.0 | 100 | 0.035 | 6.0 | PDZ423 | Z-MED-X | |
| 14.0 | 6.00 | 9 | 7.0 | 100 | 0.035 | 10.0 | PDZ643 | Z-MED II | |
| 14.0 | 6.00 | 9 | 7.0 | 100 | 0.035 | 10.0 | PDZ723 | Z-MED II-X | |
| 15.0 | 2.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ359 | Z-MED | |
| 15.0 | 3.00 | 8 | 7.0 | 100 | 0.035 | 5.0 | PDZ424 | Z-MED-X | |
| 15.0 | 3.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ335 | Z-MED | |
| 15.0 | 3.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ644 | Z-MED II | |
| 15.0 | 3.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ724 | Z-MED II-X | |
| 15.0 | 4.00 | 8 | 6.0 | 85 | 0.035 | 5.0 | SN028 | Z-MED | |
| 15.0 | 4.00 | 8 | 7.0 | 100 | 0.035 | 5.0 | PDZ425 | Z-MED-X | |
| 15.0 | 4.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ336 | Z-MED | |
| 15.0 | 4.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ725 | Z-MED II-X | |
| 15.0 | 4.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ645 | Z-MED II | |
| 15.0 | 4.00 | 9 | 8.0 | 100 | 0.035 | 5.0 | PDZ366 | Z-MED | |
| 15.0 | 5.00 | 8 | 7.0 | 100 | 0.035 | 5.0 | PDZ426 | Z-MED-X | |
| 15.0 | 5.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ361 | Z-MED | |
| 15.0 | 5.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ726 | Z-MED II-X | |
| 15.0 | 5.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ646 | Z-MED II | |
| 15.0 | 6.00 | 8 | 7.0 | 100 | 0.035 | 5.0 | PDZ427 | Z-MED-X | |
| 15.0 | 6.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ727 | Z-MED II-X | |
| 15.0 | 6.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ647 | Z-MED II | |
| 16.0 | 2.00 | 7 | 6.0 | 85 | 0.035 | 5.0 | SN029 | Z-MED | |
| 16.0 | 2.00 | 9 | 7.0 | 120 | 0.035 | 5.0 | SO066 | Z-MED | |
| 16.0 | 3.00 | 9 | 7.0 | 85 | 0.035 | 5.0 | PDZ309 | Z-MED | |
| 16.0 | 3.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ428 | Z-MED-X | |
| 16.0 | 3.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ322 | Z-MED | |
| 16.0 | 3.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ648 | Z-MED II | |
| 16.0 | 3.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ728 | Z-MED II-X | |
| 16.0 | 4.00 | 7 | 6.0 | 80 | 0.021 | 5.0 | SN030 | Z-MED | |
| 16.0 | 4.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ319 | Z-MED | |
| 16.0 | 4.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ429 | Z-MED-X | |
| 16.0 | 4.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ649 | Z-MED II | |
| 16.0 | 4.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ729 | Z-MED II-X | |
| 16.0 | 4.00 | 9 | 8.0 | 100 | 0.035 | 5.0 | PDZ367 | Z-MED | |
| 16.0 | 5.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ430 | Z-MED-X | |
| 16.0 | 5.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ650 | Z-MED II | |
| 16.0 | 5.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ730 | Z-MED II-X | |
| 16.0 | 6.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ431 | Z-MED-X | |
| 16.0 | 6.00 | 9 | 7.0 | 100 | 0.035 | 5.0 | PDZ370 | Z-MED | |
| 16.0 | 6.00 | 9 | 7.0 | 100 | 0.035 | 8.0 | PDZ731 | Z-MED II-X |
Disclaimer
All products are subject to individual country regulations in regards to the importation and/or sale of these products. Refer to Instructions for Use for a complete listing of indications, contraindications, warnings, and precautions.