Z-med-X
Presentational Presentational

Percutaneous Transluminal Valvuloplasty (International)

Z-MED(International)

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 through your local distributor.
 

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, not made with natural rubber latex.

Z-MED™: Specifications, Instructions for Use, and Forms

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, Mitral Valve and Aortic Valve

Z-MED™ IFUs:
INTERNATIONAL: RM0344-52E

Post Market Surveillance Form

Z-MED II™: Specifications, Instructions for Use, and Forms

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, Mitral Valve and Aortic Valve

Z-MED II™ IFUs:
INTERNATIONAL: RM0344-53E

Post Market Surveillance Form

Z-MED-X™: Specifications, Instructions for Use, and Forms

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™ IFUs: 
INTERNATIONAL: RM0344-09J

Post Market Surveillance Form

Z-MED II-X™: Specifications, Instructions for Use, and Forms

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™ IFUs:
INTERNATIONAL: RM0344-11J

Post Market Surveillance Form

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
2.0 2.00 6 5.5 90 0.035 10.0 SO022 Z-MED
3.0 2.00 6 5.5 90 0.035 10.0 SO024 Z-MED
3.0 4.00 6 5.5 90 0.035 10.0 SO025 Z-MED
4.0 2.00 5 5.0 100 0.025 15.0 PDZ600 Z-MED II
4.0 2.00 5 5.0 120 0.025 15.0 SN037 Z-MED II
4.0 2.00 6 5.0 85 0.025 10.0 PDZ300 Z-MED
4.0 2.00 6 5.0 100 0.025 10.0 PDZ323 Z-MED
4.0 3.00 5 5.0 100 0.025 15.0 PDZ601 Z-MED II
4.0 4.00 5 5.0 100 0.025 15.0 PDZ602 Z-MED II
4.0 5.00 5 5.0 100 0.025 15.0 PDZ603 Z-MED II
4.0 6.00 5 5.0 100 0.025 15.0 PDZ604 Z-MED II
4.0 10.00 5 5.0 100 0.025 15.0 PDZ676 Z-MED II
5.0 2.00 6 5.0 85 0.025 10.0 PDZ301 Z-MED
5.0 2.00 6 5.0 100 0.025 10.0 PDZ324 Z-MED
5.0 2.00 6 5.0 100 0.025 15.0 PDZ605 Z-MED II
5.0 2.00 6 5.0 120 0.025 15.0 SN038 Z-MED II
5.0 3.00 6 5.0 100 0.025 15.0 PDZ606 Z-MED II
5.0 4.00 6 5.0 100 0.025 15.0 PDZ607 Z-MED II
5.0 5.00 6 5.0 100 0.025 15.0 PDZ608 Z-MED II
5.0 6.00 6 5.0 100 0.025 15.0 PDZ609 Z-MED II
6.0 2.00 6 5.0 85 0.025 10.0 PDZ302 Z-MED
6.0 2.00 6 5.0 100 0.025 10.0 PDZ325 Z-MED
6.0 2.00 6 5.0 100 0.025 15.0 PDZ610 Z-MED II
6.0 2.00 6 5.0 120 0.025 15.0 SN039 Z-MED II
6.0 3.00 6 5.0 100 0.025 15.0 PDZ611 Z-MED II
6.0 3.00 7 6.0 100 0.035 10.0 PDZ344 Z-MED
6.0 4.00 6 5.0 100 0.025 15.0 PDZ612 Z-MED II
6.0 5.00 6 5.0 100 0.025 15.0 PDZ613 Z-MED II
6.0 6.00 6 5.0 100 0.025 15.0 PDZ614 Z-MED II
7.0 2.00 6 5.0 85 0.025 10.0 PDZ303 Z-MED
7.0 2.00 6 5.0 100 0.025 10.0 PDZ317 Z-MED
7.0 2.00 6 5.0 100 0.025 15.0 PDZ615 Z-MED II
7.0 2.00 6 5.0 120 0.025 15.0 SN040 Z-MED II
7.0 3.00 6 5.0 100 0.025 15.0 PDZ616 Z-MED II
7.0 4.00 6 5.0 100 0.025 15.0 PDZ617 Z-MED II
7.0 5.00 6 5.0 100 0.025 15.0 PDZ618 Z-MED II
7.0 6.00 6 5.0 100 0.025 15.0 PDZ619 Z-MED II
8.0 2.00 7 6.0 85 0.035 10.0 PDZ304 Z-MED
8.0 2.00 7 6.0 100 0.035 10.0 PDZ400 Z-MED-X
8.0 2.00 7 6.0 100 0.035 10.0 PDZ326 Z-MED
8.0 2.00 7 6.0 100 0.035 15.0 PDZ700 Z-MED II-X
8.0 2.00 7 6.0 100 0.035 15.0 PDZ620 Z-MED II
8.0 2.00 7 6.0 120 0.035 15.0 SN041 Z-MED II
8.0 3.00 7 6.0 100 0.035 10.0 PDZ401 Z-MED-X
8.0 3.00 7 6.0 100 0.035 10.0 PDZ327 Z-MED
8.0 3.00 7 6.0 100 0.035 15.0 PDZ701 Z-MED II-X
8.0 3.00 7 6.0 100 0.035 15.0 PDZ621 Z-MED II
8.0 4.00 7 6.0 100 0.035 10.0 PDZ402 Z-MED-X
8.0 4.00 7 6.0 100 0.035 15.0 PDZ622 Z-MED II
8.0 4.00 7 6.0 100 0.035 15.0 PDZ702 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.

 

NuMED for Children

9100 Conroy Windermere Rd - Suite 200
Windermere, FL
34786 USA
Tel: 407-352-5200

 

NuMED Inc.

2880 Main Street
Hopkinton, NY
12965 USA
Tel: 315-328-4491

 

NuMED Canada

45 Second Street West
Cornwall, Ontario
K6J1G3 CANADA
Tel: 613-936-2592