NuDEL Stent Delivery System in Action

NuDEL™ Stent Delivery System: A Game Changer for Complex Congenital Heart Procedures?

Mira Elwood in Health & Wellness November 2025 • 4 min read.

"Explore how the innovative NuDEL™ system is transforming covered stent implantation, offering safer and more effective solutions for challenging cardiovascular anatomies. Discover the benefits and future implications of this cutting-edge technology."

Stent implantation has become a cornerstone in treating right ventricular outflow tract (RVOT) obstructions and aortic coarctation. The field of congenital interventional cardiology has increasingly relied on these methods, with a growing array of stent options to suit individual cases. However, the precision and safety of stent deployment hinge significantly on the accuracy of mounting the stent onto the delivery balloon and navigating it through the delivery sheath to the target location.

As medical advancements bring more complex anatomies into the catheterisation laboratory, the challenges associated with stent delivery have escalated. The most critical phase often involves maneuvering the stent into the precise anatomical position before deployment. This stage is laden with potential pitfalls, including stent slippage leading to migration, as well as damage to the balloon or stent during mounting. Such complications may necessitate re-crossing of target areas and increase vascular risks due to repeated insertions of large-calibre sheaths, which can compromise patient safety.

To mitigate these risks and streamline the delivery of covered stents, the NuDEL™ system was developed by Numed Inc. in Hopkinton, New York. This system features a covered Cheatham-Platinum stent pre-mounted on a balloon-in-balloon system of matched length and diameter. It comes pre-loaded in a long, non-braided delivery sheath, poised to transform the landscape of stent delivery.

How Does NuDEL™ Streamline Stent Delivery and Enhance Safety?

NuDEL Stent Delivery System in Action

The NuDEL™ system simplifies stent deployment through an integrated design. It includes a covered, 8-zig Cheatham-Platinum stent mounted on a balloon-in-balloon system, matched in length and diameter, and pre-loaded on a long, non-braided delivery sheath. This design is intended to minimize risks associated with manual stent mounting and navigation.

Deployment is streamlined into three straightforward steps:

Positioning: Once the system is in place, the stent is fully uncovered by retracting the sheath. Distal fluoroscopic markers and markers on the balloon catheter shaft ensure precise positioning.
Inflation: The balloon-in-balloon is inflated in the standard way.
Withdrawal: After stent deployment and balloon deflation, the sheath tip is brought into contact with the nose cone, and the entire assembly is removed over the wire.

This method simplifies what can often be a complex procedure, reducing potential complications and improving overall efficiency.

The Future of Stent Delivery with NuDEL™

The NuDEL™ delivery system marks a significant step forward in the field of congenital interventional cardiology. Its design addresses many challenges associated with traditional stent delivery, offering a safer, more efficient approach. As research continues and the technology evolves, the NuDEL™ system promises to improve outcomes for patients undergoing complex cardiovascular procedures. This innovation is set to become a crucial tool in modern cardiology, enhancing the precision and reliability of stent implantation.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1017/s1047951117000488, Alternate LINK

Title: Initial Assessment Of A Novel Delivery System (Nudel^™^®) For The Covered Cheatham-Platinum Stent

Subject: Cardiology and Cardiovascular Medicine

Journal: Cardiology in the Young

Publisher: Cambridge University Press (CUP)

Authors: Gareth J. Morgan, Damien Kenny, Christopher Duke, Kevin P. Walsh, Shakeel A. Qureshi

Published: 2017-06-15

Everything You Need To Know

1

What is the NuDEL™ Stent Delivery System, and what is its primary purpose in congenital heart procedures?

The NuDEL™ delivery system is an innovative system designed to improve covered stent implantation during complex congenital heart procedures. Its primary purpose is to offer safer and more effective solutions for challenging cardiovascular anatomies by streamlining stent deployment and reducing complications associated with traditional methods. The system's pre-mounted design minimizes risks associated with manual stent mounting and navigation, enhancing precision and reliability.

2

How does the NuDEL™ system address the challenges associated with traditional stent delivery methods, particularly concerning stent slippage and vascular risks?

The NuDEL™ system mitigates risks such as stent slippage and vascular damage through its integrated design. It features a covered Cheatham-Platinum stent pre-mounted on a balloon-in-balloon system and pre-loaded on a long, non-braided delivery sheath. This setup minimizes the need for manual stent mounting and extensive navigation, reducing the likelihood of stent migration and repeated insertions of large-calibre sheaths. By simplifying the deployment process, the NuDEL™ system enhances patient safety and reduces potential complications.

3

What are the key components of the NuDEL™ delivery system, and how do they contribute to its streamlined deployment process?

The NuDEL™ delivery system includes a covered 8-zig Cheatham-Platinum stent, a balloon-in-balloon system matched in length and diameter to the stent, and a long, non-braided delivery sheath. The pre-mounted stent eliminates manual handling, while the balloon-in-balloon system facilitates precise inflation and deployment. Distal fluoroscopic markers and markers on the balloon catheter shaft further ensure accurate positioning. The sheath retracts to uncover the stent, and after deployment, it's brought into contact with the nose cone for safe removal. These components work together to simplify and streamline stent deployment.

4

What are the implications of using the NuDEL™ system in modern cardiology, and how might it evolve in the future?

The NuDEL™ delivery system represents a significant advancement in modern cardiology by enhancing the precision and reliability of stent implantation. Its design addresses many challenges associated with traditional stent delivery, potentially leading to improved outcomes for patients undergoing complex cardiovascular procedures. As research continues, the technology may evolve to accommodate a wider range of stent sizes and anatomical variations, further expanding its utility in treating congenital heart conditions. This innovation is set to become a crucial tool in modern cardiology, enhancing the precision and reliability of stent implantation.

5

Can you explain the three straightforward steps involved in deploying a stent using the NuDEL™ system, and why is each step critical for a successful procedure?

The deployment of a stent using the NuDEL™ system involves three key steps: Positioning, Inflation, and Withdrawal. Positioning involves retracting the sheath to fully uncover the stent at the target location, guided by distal fluoroscopic markers and markers on the balloon catheter shaft, ensuring precise placement. Inflation uses the balloon-in-balloon system to deploy the stent. Withdrawal involves deflating the balloon and bringing the sheath tip into contact with the nose cone for safe removal of the assembly over the wire. Each step is crucial: accurate positioning ensures the stent is placed correctly to treat the obstruction or defect, controlled inflation ensures proper stent expansion without damaging surrounding tissue, and careful withdrawal prevents dislodgement or vascular trauma.