We are pleased to announce that our Renova Detachable Coil has officially obtained the China Medical Device Registration Certificate and the China Free Sale Certificate (FSC) for export.
This milestone affirms the quality, safety, and regulatory compliance of our neurovascular embolization product, enabling us to better serve both the domestic Chinese market and international partners.
Indications
Renova Detachable Coil is intended for endovascular embolization of:
- Intracranial aneurysms
- Neurovascular abnormalities, including arteriovenous malformations (AVMs) and arteriovenous fistulae (AVFs)
- Arterial and venous embolizations in the peripheral vasculature
Key Features & Benefits
Optimized Coil Shapes
- Open loop configuration conforms to various aneurysm morphologies
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The first 1.5 loops are 25% smaller than the stated secondary coil diameter, effectively reducing the risk of coil herniation
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Open center design allows for concentric filling
Proprietary Instant Mechanical Detachment System
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Manual break mechanism enables instant detachment
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Shorter detachment zone minimizes microcatheter kick-back
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Dual feedback (tactile and visual) ensures reliable operation
Hybrid Delivery Shaft
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Provides balanced flexibility and pushability
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Enables smooth, predictable delivery to target sites
Comprehensive Portfolio
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Available in multiple softness levels and sizes
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Covers the full spectrum from frame formation to filling and finishing
Regulatory Status
With the China Medical Device Registration Certificate and FSC now in place, the Renova Detachable Coil is fully authorized for commercial distribution in China and eligible for export to markets that recognize the Chinese FSC.
We remain committed to delivering high-quality, innovative neurovascular solutions to support clinicians in achieving better patient outcomes.
Contact Us
For inquiries, distribution partnerships, or technical information, please feel free to contact us through our website or reach out to our sales team.