By Fineline Cube Sino Medical Sciences Technology Inc. (SHA: 688108) announced that the COMETIU self‑expanding intracranial drug‑eluting stent system, independently developed by its subsidiary Neurovita, has obtained EU CE certification under the Medical Device Regulation (MDR). The certification clears the European market for what the company describes as the world’s first nitinol self‑expanding drug‑eluting stent system specifically designed for intracranial atherosclerotic stenosis.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Sino Medical Sciences Technology Inc. (SHA: 688108), via subsidiary Neurovita |
| Product | COMETIU self‑expanding intracranial drug‑eluting stent system |
| Certification | EU CE certification under Medical Device Regulation (MDR) |
| Indication | Intracranial atherosclerotic stenosis |
| Announcement Date | 10 Aug 2026 |
Device Profile & Design
- First‑in‑Class: The world’s first nitinol self‑expanding drug‑eluting stent system specifically designed for intracranial atherosclerotic stenosis
- Stent Architecture: Closed‑cell asymmetric polygonal mesh design
- Drug Coating Structure:
- Base layer: poly (butyl methacrylate) (PBuMA)
- Drug layer: biodegradable polymer layer (PLGA) containing sirolimus
- Coating Technology: Combines electrografting coating technology with controlled‑release drug loading to enable targeted drug release
- Dual Benefit: Balances optimal self‑expansion and wall apposition after microcatheter delivery with effective inhibition of vascular in‑stent restenosis
Market Impact & Outlook
- Regulatory Gateway: EU MDR CE certification — one of the most demanding pathways for medical devices — positions COMETIU for commercialization across the European market through Sino Medical Sciences’ international channels.
- Unmet Clinical Need: Intracranial atherosclerotic stenosis carries high stroke risk and limited treatment options; a device purpose‑built for intracranial anatomy, rather than adapted from coronary platforms, addresses a distinct clinical segment.
- Restenosis Solution: By pairing self‑expansion mechanics with sirolimus‑based controlled drug release, COMETIU targets in‑stent restenosis — a key failure mode in intracranial stenting — while preserving deliverability through microcatheter navigation of tortuous cerebral vasculature.
- Category Leadership: As the first nitinol self‑expanding drug‑eluting stent of its kind to reach CE certification, Neurovita’s device establishes a reference point in a nascent category of intracranial drug‑eluting implants.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the commercialization of the COMETIU intracranial drug‑eluting stent system in Europe. Actual results may differ due to risks including market adoption, competitive dynamics, and regulatory developments.-Fineline Info & Tech