====== COPERNIC RC - Venous Remodeling Balloon ======

**Innovation, made to measure**  
[[https://www.balt.fr|www.balt.fr]]  
Balt Extrusion continues to manufacture its entire portfolio in Europe.  

10, rue de la Croix Vigneron  
Tél. : +33 (0)1 39 89 46 41  

===== 🧠 Indication =====

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.

===== 🎯 Purpose =====

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

===== 💡 Background =====

> 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.

===== 🧪 Technical Features =====

^ Reference           ^ Balloon length (mm) ^ Balloon diameter (mm) ^ Catheter length (cm) ^ Max. outer diameter (F / mm) ^ Guidewire compatibility ^ Compatible guiding catheter         ^
| COPERNIC8X80RC     | 8                   | 8                      | 160                   | 4.35F / 1.45 mm              | Transend14 (Stryker\*)   | FARGO MAX 6F (I.D. 1.78 mm / .070") |
| COPERNIC10X80RC    | 10                  | 10                     | 160                   | 5F / 1.6 mm                  | Transend14 (Stryker\*)   | FARGO MAX 6F                         |

* \* Other guidewires may induce risk of leakage.

===== 🚀 Navigation Features =====

* **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

===== 📌 Summary =====

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  

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**Source**: BALT Extrusion – [[https://www.balt.fr|balt.fr]]  
Product code: DC027GB–2013/12

===== Case reports =====

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
((Noda R, et al. Microcatheter navigation using a large compliant balloon placed in a cortical vein during transvenous access. *J Neurointerv Surg*. 2025 Jun 24. doi:10.1136/jnis‑2025‑023596.)).
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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  

==== Final Verdict ====
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.

==== Takeaway for Neurosurgeons ====
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.

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

==== Numeric Rating (0–10) ====
2/10 – Innovative idea, but unjustified risk and devoid of follow‑up or comparative evidence.

==== Citation ====
  * Published online ahead of print June 24, 2025.
  * Corresponding author email: [[izzatarslan@gmail.com]]