NuCLEUS-X™
Percutaneous Transluminal Valvuloplasty (USA)
NuCLEUS-X™
NuCLEUS-X™catheters feature an innovative balloon designed with a waist formed in the middle of the balloon to facilitate positive positioning while holding the balloon in the correct location prior to and during inflation. NuCLEUS-X™ balloon catheters are suitable for PTV and pre-dilatation in transcatheter heart-valve replacement procedures. Upon reaching a specified pressure, the waist will expand between 90% to almost 100% of the rated balloon diameter. The NuCLEUS-X™ is available in a range of diameters (18.0-30.0mm) and lengths (4.0-6.0cm).
Unique Benefits
NuCLEUS-X™ PTV balloons are coaxially constructed with a non-compliant balloon suitable for resistant stenosis. The balloon design facilitates precise positioning and helps to maintain the correct balloon location throughout the procedure. The NuCLEUS-X™ has an extra high inner lumen strength due to the braided inner tubing. The increased pushability of the coaxial shaft provides outstanding tracking performance. They have extremely fast inflation and deflation times for a quick procedure.
The catheter body is Polymeric, DEHP-free, and not made with natural rubber latex. The balloon is a thermoplastic elastomer; non-compliant - which will not exceed +/- 10% of the labeled balloon size at RBP, is DEHP-free, and not made with natural rubber latex.
Specifications and Instructions for Use
Balloon Diameters (mm): 18.0-30.0
Balloon Lengths (cm): 4.0-6.0
Rated Burst Pressure (ATM): 2-4
Introducer Size (FR): 10-14
Indication: PTV of the Pulmonary & Aortic Valve
NuCLEUS-X™ IFU:
USA: IFU-230XB
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 18.0 | 4.00 | 10 | 9.0 | 110 | 0.035 | 4.0 | PVN400 | NUCLEUS-X | |
| 18.0 | 5.00 | 10 | 9.0 | 110 | 0.035 | 4.0 | PVN401 | NUCLEUS-X | |
| 18.0 | 6.00 | 10 | 9.0 | 110 | 0.035 | 4.0 | PVN402 | NUCLEUS-X | |
| 20.0 | 4.00 | 12 | 9.0 | 110 | 0.035 | 4.0 | PVN403 | NUCLEUS-X | |
| 20.0 | 5.00 | 12 | 9.0 | 110 | 0.035 | 4.0 | PVN404 | NUCLEUS-X | |
| 20.0 | 6.00 | 12 | 9.0 | 110 | 0.035 | 4.0 | PVN405 | NUCLEUS-X | |
| 22.0 | 4.00 | 12 | 9.0 | 110 | 0.035 | 3.0 | PVN406 | NUCLEUS-X | |
| 22.0 | 5.00 | 12 | 9.0 | 110 | 0.035 | 3.0 | PVN407 | NUCLEUS-X | |
| 22.0 | 6.00 | 12 | 9.0 | 110 | 0.035 | 3.0 | PVN408 | NUCLEUS-X | |
| 25.0 | 4.00 | 12 | 9.0 | 110 | 0.035 | 3.0 | PVN409 | NUCLEUS-X | |
| 25.0 | 5.00 | 12 | 9.0 | 110 | 0.035 | 3.0 | PVN410 | NUCLEUS-X | |
| 25.0 | 6.00 | 12 | 9.0 | 110 | 0.035 | 3.0 | PVN411 | NUCLEUS-X | |
| 28.0 | 4.00 | 12 | 9.0 | 110 | 0.035 | 2.0 | PVN412 | NUCLEUS-X | |
| 28.0 | 5.00 | 12 | 9.0 | 110 | 0.035 | 2.0 | PVN413 | NUCLEUS-X | |
| 28.0 | 6.00 | 12 | 9.0 | 110 | 0.035 | 2.0 | PVN414 | NUCLEUS-X | |
| 30.0 | 4.00 | 14 | 9.0 | 110 | 0.035 | 2.0 | PVN415 | NUCLEUS-X | |
| 30.0 | 5.00 | 14 | 9.0 | 110 | 0.035 | 2.0 | PVN416 | NUCLEUS-X | |
| 30.0 | 6.00 | 14 | 9.0 | 110 | 0.035 | 2.0 | PVN417 | NUCLEUS-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.