NuDEL™ All-In-One Stent Delivery System
Stents
NuDEL™ All-In-One Stent Delivery System
The NuDEL™ is an innovative all-in-one Covered CP Stent delivery system which is designed for the efficient and effective treatment of Coarctation of the Aorta and Right Ventricular Outflow Tract (RVOT). The system includes the proven technologies of the Covered CP Stent™, mounted on a Balloon-in-Balloon (BIB®) catheter, which is covered by an introducer sheath. The NuDEL™ system is available with a Covered CP Stent™ ranging from 1.6-4.5 cm lengths, and BIB® outer balloon diameters available in 12.0-24.0 mm. The NuDEL™is only available in an 8 zig configuration.
Unique Benefits of the NuDEL™ System
The All-In-One system includes all components which are pre-loaded, saving time and allowing for quick action in emergency situations. The system includes a BIB® catheter and a Covered CP Stent™ which is covered by an introducer sheath. The Covered CP Stent™ is made of platinum/iridium wire arranged in a “zig” pattern. Every point of intersection is laser welded and brazed with 24K gold. The stent covering is made of ePTFE.
The catheter body is 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, are DEHP-free, and not made with natural rubber latex.
Specifications, Instructions for Use, and Forms
Stent Lengths (cm): 1.6-4.5
Sheath Sizes (FR): 12 & 14
Balloon Diameters (mm): 12.0-24.0
Balloon Lengths (cm): 2.5-5.0
Outer Balloon Rated Burst Pressure (ATM): 3-7
Indications: Implantation in native and/or recurrent coarctation of the aorta and RVOT
NuDEL™ IFUs:
US: IFU-423US
CANADA (Sterile): RM0344-64D
INTERNATIONAL (Sterile): RM0344-64D
| NuDEL™ REF | Stent Configuration (Zigs) | Stent Length (cm) | Outer Balloon Diameter (mm) | Outer Balloon Length (cm) | Profile Size (FR) | Usable Length (cm) | Guide Wire (inches) | Rated Burst (ATM) |
|---|---|---|---|---|---|---|---|---|
| DEL001 | 8 | 1.6 | 12 | 3 | 12 | 100 | 0.035 | 7.00 |
| DEL002 | 8 | 1.6 | 14 | 3 | 12 | 100 | 0.035 | 6.00 |
| DEL003 | 8 | 1.6 | 16 | 3 | 12 | 100 | 0.035 | 5.00 |
| DEL004 | 8 | 2.2 | 12 | 3 | 12 | 100 | 0.035 | 7.00 |
| DEL005 | 8 | 2.2 | 14 | 3 | 12 | 100 | 0.035 | 6.00 |
| DEL006 | 8 | 2.2 | 16 | 3 | 12 | 100 | 0.035 | 5.00 |
| DEL007 | 8 | 2.2 | 18 | 3 | 14 | 100 | 0.035 | 4.00 |
| DEL008 | 8 | 2.8 | 14 | 3 | 12 | 100 | 0.035 | 6.00 |
| DEL009 | 8 | 2.8 | 16 | 3 | 12 | 100 | 0.035 | 5.00 |
| DEL010 | 8 | 2.8 | 18 | 3 | 14 | 100 | 0.035 | 4.00 |
| DEL011 | 8 | 2.8 | 20 | 3 | 14 | 100 | 0.035 | 4.00 |
| DEL012 | 8 | 3.4 | 14 | 4 | 12 | 100 | 0.035 | 6.00 |
| DEL013 | 8 | 3.4 | 16 | 4 | 12 | 100 | 0.035 | 5.00 |
| DEL014 | 8 | 3.4 | 18 | 4 | 14 | 100 | 0.035 | 4.00 |
| DEL015 | 8 | 3.4 | 20 | 4 | 14 | 100 | 0.035 | 4.00 |
| DEL016 | 8 | 3.4 | 22 | 4 | 14 | 100 | 0.035 | 3.00 |
| DEL017 | 8 | 3.9 | 14 | 4 | 12 | 100 | 0.035 | 6.00 |
| DEL018 | 8 | 3.9 | 16 | 4 | 12 | 100 | 0.035 | 5.00 |
| DEL019 | 8 | 3.9 | 18 | 4 | 14 | 100 | 0.035 | 4.00 |
| DEL020 | 8 | 3.9 | 20 | 4 | 14 | 100 | 0.035 | 4.00 |
| DEL021 | 8 | 3.9 | 22 | 4 | 14 | 100 | 0.035 | 3.00 |
| DEL022 | 8 | 3.9 | 24 | 4 | 14 | 100 | 0.035 | 3.00 |
| DEL023 | 8 | 4.5 | 14 | 5 | 12 | 100 | 0.035 | 6.00 |
| DEL024 | 8 | 4.5 | 16 | 5 | 12 | 100 | 0.035 | 5.00 |
| DEL025 | 8 | 4.5 | 18 | 5 | 14 | 100 | 0.035 | 4.00 |
| DEL026 | 8 | 4.5 | 20 | 5 | 14 | 100 | 0.035 | 4.00 |
| DEL027 | 8 | 4.5 | 22 | 5 | 14 | 100 | 0.035 | 3.00 |
| DEL028 | 8 | 4.5 | 24 | 5 | 14 | 100 | 0.035 | 3.00 |
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.