Heart with stent

NuDEL™ System: The Future of Stent Delivery in Complex Heart Conditions?

Lena Kashyap in Health & Wellness November 2025 • 3 min read.

"A groundbreaking system promises safer and more effective covered stent deployment, particularly in challenging anatomical conditions, marking a significant advancement in pediatric and adult congenital cardiology."

Stent implantation has become a cornerstone in treating conditions like right ventricular outflow tract obstruction and aortic coarctation, congenital heart disease which requires skilled cardiologist to safely perform, Stents correct narrowed or blocked vessels, improving blood flow and overall cardiac function. Ensuring the safety and accuracy of stent placement is critical.

Traditional methods of stent delivery can present challenges, particularly when dealing with complex anatomy. The process involves mounting the stent on a delivery balloon, navigating it through a sheath, and positioning it accurately. Each step carries potential risks, including stent slippage, balloon damage, and vascular trauma, which can lead to complications and require additional interventions.

To address these issues, the NuDEL™ system was developed by Numed Inc. This innovative system streamlines the delivery of covered stents. It combines a covered Cheatham-Platinum stent with a balloon-in-balloon system, pre-mounted and loaded in a long delivery sheath, aiming to simplify the procedure and reduce the risk of complications.

What is the NuDEL™ System and How Does It Work?

Heart with stent

The NuDEL™ system represents a significant advancement in stent delivery technology. It consists of a covered Cheatham-Platinum stent pre-mounted on a specialized balloon-in-balloon system. This assembly is pre-loaded within a long, non-braided delivery sheath, simplifying the preparation and deployment process. A short, tapered nose cone is thermal-bonded to the end of the balloon shaft, replacing the standard dilator.

Deployment of the stent involves a streamlined three-step process:

Positioning: The stent is navigated to the target location within the vessel.
Uncovering: The sheath is withdrawn, exposing the stent, guided by fluoroscopic markers that ensure precise placement.
Inflation: The balloon-in-balloon system is inflated to expand the stent, securing it in the desired position.

After deployment, the sheath is repositioned over the deflated balloon and nose cone, allowing the entire assembly to be safely withdrawn over the wire. This integrated design aims to reduce the potential for stent migration or damage during the procedure.

Future Implications and Innovations

The NuDEL™ system represents a promising advancement in covered stent delivery, offering a potentially safer, more efficient method for treating complex cardiovascular conditions. As technology evolves, further refinements to sheath design and system ergonomics could enhance its utility. This technology also allows for rapid deployment of covered stents in emergency situations, such as conduit rupture, or in situations involving iatrogenic aortic dissection. Continuous innovation in delivery systems is crucial for improving patient outcomes.

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Everything You Need To Know

1

What is the NuDEL™ system, and what makes it different from traditional stent delivery methods?

The NuDEL™ system is an innovative stent delivery technology developed by Numed Inc. It distinguishes itself through its streamlined design, featuring a covered Cheatham-Platinum stent pre-mounted on a balloon-in-balloon system and pre-loaded in a long delivery sheath. Unlike traditional methods that involve multiple steps and potential risks such as stent slippage or vascular trauma, the NuDEL™ system simplifies the process into three steps: positioning, uncovering, and inflation. This integrated approach aims to enhance accuracy and reduce complications during stent deployment, especially in complex anatomical conditions.

2

How does the balloon-in-balloon system within the NuDEL™ system contribute to safer stent deployment?

The balloon-in-balloon system is a crucial component of the NuDEL™ system. It allows for controlled and precise stent expansion. Once the covered Cheatham-Platinum stent is positioned at the target location, the balloon-in-balloon system is inflated to securely expand the stent against the vessel wall. After deployment, the deflated balloon is covered by repositioning the sheath over it and the nose cone. The whole assembly can then be safely withdrawn over the wire. This design minimizes the risk of stent migration or damage during the removal process, enhancing the safety profile of the NuDEL™ system.

3

What are the primary benefits of using the NuDEL™ system in patients with complex structural heart diseases?

The NuDEL™ system offers several benefits for patients with complex structural heart diseases. Its streamlined design simplifies the stent delivery process, potentially reducing the risk of complications associated with traditional methods. The pre-mounted covered Cheatham-Platinum stent on the balloon-in-balloon system, combined with the long delivery sheath, enhances accuracy and control during deployment. Additionally, the NuDEL™ system's design allows for rapid deployment of covered stents in emergency situations, such as conduit rupture or iatrogenic aortic dissection. These advantages make it a promising solution for treating challenging cardiovascular conditions.

4

What specific types of stents are compatible with the NuDEL™ system, and why is this important for treating conditions like aortic coarctation?

The NuDEL™ system is specifically designed to deliver covered Cheatham-Platinum stents. These stents are particularly beneficial in treating conditions like aortic coarctation, where the aorta is narrowed. The 'covered' aspect of the stent is important because it provides a barrier that can prevent complications such as vessel perforation or aneurysm formation after stent placement. The Cheatham-Platinum material offers a balance of flexibility and radiopacity, allowing for precise placement and visibility under fluoroscopy. The combination of the covered stent and the NuDEL™ delivery system provides a targeted solution for addressing aortic coarctation and similar vascular conditions.

5

What future innovations or enhancements could further improve the utility and effectiveness of the NuDEL™ system for stent delivery?

Future innovations could focus on refining the sheath design of the NuDEL™ system to improve navigation and reduce friction during deployment. Enhancements to the system's ergonomics could also make it easier for physicians to handle and maneuver, potentially shortening procedure times and improving outcomes. Further research could explore the use of advanced imaging techniques to enhance the precision of stent placement with the NuDEL™ system. Additionally, innovations in stent materials and coatings could further reduce the risk of complications such as thrombosis or restenosis, making the NuDEL™ system even more effective in treating complex cardiovascular conditions.