NuCLEUS™ and NuCLEUS-X™
Percutaneous Transluminal Valvuloplasty (Canada)
NuCLEUS™ and NuCLEUS-X™
NuCLEUS™ and 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. The NuCLEUS-X™ catheter features a braided inner tubing which provides high inner lumen strength for increased pushability. Upon reaching a specified pressure, the waist will expand between 90% to almost 100% of the rated balloon diameter. The NuCLEUS™ and NuCLEUS-X™ catheters are indicated for PTV of the mitral and aortic valves. The NuCLEUS™ is available in diameters ranging from 10.0-30.0mm and lengths of 3.0-6.0cm, and the NuCLEUS-X™ is available in diameters ranging from 18.0-30.0mm and lengths of 4.0-6.0cm.
Unique Benefits
NuCLEUS™ and NuCLEUS-X™ PTV catheters are coaxially constructed with a non-compliant high pressure 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.
NuCLEUS™: Specifications, Instructions for Use, and Forms
Balloon Diameters (mm): 10.0-30.0
Balloon Lengths (cm): 3.0-6.0
Rated Burst Pressure (ATM): 2-9
Introducer Size (FR): 7-14
Indication: PTV of the Mitral & Aortic Valve
NuCLEUS™ IFUs:
INTERNATIONAL: RM0344-24I
CANADA: RM0344-24I
NuCLEUS-X™: Specifications, Instructions for Use, and Forms
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 Mitral & Aortic Valve
NuCLEUS-X™
CANADA: RM0344-30K
INTERNATIONAL: RM0344-30K
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 30.0 | 4.00 | 14 | 9.0 | 110 | 0.035 | 2.0 | PVN415 | NUCLEUS-X | |
| 30.0 | 4.00 | 14 | 9.0 | 110 | 0.035 | 2.0 | PVN235 | NUCLEUS | |
| 30.0 | 5.00 | 14 | 9.0 | 110 | 0.035 | 2.0 | PVN416 | NUCLEUS-X | |
| 30.0 | 5.00 | 14 | 9.0 | 110 | 0.035 | 2.0 | PVN254 | NUCLEUS | |
| 30.0 | 6.00 | 14 | 9.0 | 110 | 0.035 | 2.0 | PVN417 | NUCLEUS-X | |
| 30.0 | 6.00 | 14 | 9.0 | 110 | 0.035 | 2.0 | PVN255 | NUCLEUS |
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.