DEL
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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

Post Market Surveillance Form

Implant Cards

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.

 

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