COPERNIC RC - Venous Remodeling Balloon

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The Venous Remodeling Technique in the treatment of dural arteriovenous fistulas (dAVFs) was developed by Pr. René Chapot (Alfried Krupp Krankenhaus, Essen, Germany). This technique aims to preserve the venous sinus during embolization of meningeal feeders.

* Occlusion of sinus with the balloon’s long length * Rerouting of embolic agents by temporary occlusion * Controlled procedure with high visibility * DMSO compatible

Initially, angioplasty PTA balloons were used, but they lacked navigability and compliance.
To overcome this, BALT developed a dedicated venous remodeling balloon — the COPERNIC RC, designed for better flexibility, length, and ease of use.

* \* Other guidewires may induce risk of leakage.

* HYDROSPEED coating on the balloon for easy navigation * Introduction via femoral venous puncture * Navigated to sinus with 6F guiding catheter (FARGOMAX) * Arterial approach for embolic agent injection * Balloon inflation diverts flow toward remaining feeders

The COPERNIC RC balloon is specifically designed for sinus protection during embolization of dural AVFs, providing:

• Flexibility
• High compliance
• Length suitable for sinus occlusion
• Visibility and navigation ease
• Compatibility with standard neurointerventional equipment

Source: BALT Extrusion – balt.fr Product code: DC027GB–2013/12

In a Video technique demonstration / Case report Noda et al. from:

• Neuroradiologie Interventionelle, CHU Limoges, Limoges, France
• Neurosurgery, NTT Medical Center Tokyo, Shinagawa‑ku, Japan
• Radiology Department, Universiti Kebangsaan Malaysia, Fakulti Perubatan, Cheras, Malaysia
• Published in the Journal of NeuroInterventional Surgery

with the purpose to demonstrate feasibility and safety of using a large compliant balloon positioned in a cortical vein to support microcatheter navigation for transvenous embolization of a brain AVM They concluded that the large compliant Copernic RC balloon provided stable “buttress” support in a cortical draining vein, enabling safe and successful microcatheter cannulation during TVE in a challenging bAVM case, without complications ¹⁾.

This video-based single‑case technique report suffers from severe limitations:

• n=1 restricts external validity—no statistical support or comparison with standard microcatheter techniques
• No quantitative bench testing or phantom models to define force thresholds, risks of venous rupture, or balloon‑catheter interaction
• Balloon in cortical veins raises significant safety concerns: potential for endothelial injury, venous thrombosis, or rupture—no monitoring or follow‑up imaging provided
• Technique complexity—introducing a compliant balloon into fragile veins may add procedural risk not fully acknowledged
• No long‑term clinical outcomes documented; absence of angiographic follow‑up to confirm AVM obliteration or highlight delayed venous injury undermines claims
• Lack of multi-operator reproducibility or ergonomic feasibility—unclear learning curve or required expertise

This contribution is a rudimentary proof‑of‑concept overshadowed by major safety, validity, and reproducibility concerns. Valuable as an exploratory video, but not robust evidence.

A novel balloon-assisted approach shows technical promise in select TVE scenarios—but red flags abound: extremely cautious use, rigorous safety protocols, and comparative studies are mandatory before adoption.

One-case video demonstration only; attractive in concept but currently lacks scientific rigour and safety validation—far from practice-changing.

2/10 – Innovative idea, but unjustified risk and devoid of follow‑up or comparative evidence.

• Published online ahead of print June 24, 2025.
• Corresponding author email: izzatarslan@gmail.com