Nickel Titanium Alloy Empowers Neurointervention: Domestic Intracranial Stent Secures EU MDR Certification For Overseas Expansion
Aug 18, 2026
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In recent years, as a core critical material for high‑end medical devices, nickel‑titanium shape‑memory alloy has witnessed expanding applications in neurointervention and cardiovascular intervention. COMETIU self‑expanding drug‑coated intracranial stent system, developed by SinoNeuroCharm, a holding subsidiary of Sinomed, has obtained EU MDR CE certification. It is the world's first intracranial stent in its category to achieve this certification. This breakthrough is strongly backed by nickel‑titanium alloy materials.
I.Material Advantages and Core Product Specifications
1. Application scenario
Intracranial vascular surgery sets very high requirements for implantable devices. Due to tortuous and slim intracranial vessels, stents need super‑elasticity, fatigue resistance, radial‑support property and favourable biocompatibility.
2. Base material & working principle
‑ Substrate: precisely‑engraved nickel‑titanium‑alloy tube
‑ Leveraging shape‑memory and super‑elastic features of Ni‑Ti alloy.
‑ The crimped stent travels through narrow, winding intracranial vessels together with the delivery system.
‑ Auto‑expands at the lesion site, apposes to vessel wall and delivers stable support for stenotic vessels.
3. Dual‑layer coating system
‑ Bottom layer: PBuMA base coating
‑ Top layer: degradable PLGA coating loaded with sirolimus
4. Structure & drug‑release technology
‑ Proprietary closed‑loop asymmetric‑mesh design
‑ Controlled‑drug‑release technology
‑ Provides good vessel conformity; released‑drug suppresses vascular restenosis; addresses clinical‑pain‑points of intracranial atherosclerotic‑stenosis.
5. Indications
‑ Target‑population: patients with ＞70 %‑vascular‑stenosis and poor‑response‑to‑pharmacotherapy
‑ Fit‑reference‑vessel‑diameter: 2.0‑4.5 mm
‑ Maximum‑treatable‑lesion‑length: 34 mm
6. Sterilization & shelf‑life
‑ Sterilization: electron‑beam sterilization
‑ Shelf‑life: 2‑years
II. Significance of EU MDR Certification and Domestic Industrial‑chain Progress
1. EU MDR regulatory requirement
‑ The EU MDR represents the world's most stringent‑access threshold for high‑risk implantable medical devices.
‑ Compared with the former MDD Directive, MDR has‑elevated overall requirements for clinical evidence, technical documentation, production quality‑control and post‑market surveillance, resulting in substantially stricter assessment procedures.
2. Significance of MDR certification
‑ Successful‑completion of rigorous MDR assessment verifies that Sinomed's product‑design and manufacturing quality‑control‑system meet‑international‑standards.
‑ It also indicates that domestic nickel‑titanium‑alloy processing, precision‑engraving and coating‑technologies have‑reached‑world‑class‑level.
3. Market background
‑ For‑a‑long‑time, overseas‑products have‑dominated‑China's high‑end‑neuro‑intervention‑market.
‑ Domestic‑medical‑devices‑have‑faced‑major‑barriers‑when‑entering‑mainstream‑European‑and‑American‑markets.
4. Technical‑challenges for intracranial stents (Class III high‑risk implantable device)
‑ Multiple‑formidable‑technical‑barriers: tube‑fabrication, laser‑cutting, deburring, surface‑modification and‑drug‑coating‑manufacturing.
‑ Purity, uniformity and‑fatigue‑resistance of nickel‑titanium‑alloy‑tubes directly‑govern‑the‑long‑term‑in‑vivo‑safety‑of‑stents‑within‑blood‑vessels.
‑ Strict‑control‑is‑mandatory‑for‑all‑manufacturing‑details.
III. Challenges for Overseas Commercialization after Certification
1. Position of EU MDR certification
‑ Obtaining EU MDR certification is only the first‑step for domestic medical‑devices‑to‑go‑global.
‑ This certification is valid‑only‑in the European‑Union and European‑Economic‑Area.
‑ Additional‑registration‑submissions‑are‑required‑for‑other‑countries‑and‑regions.
2. Work involved in overseas commercialization
‑ Overseas‑commercialization‑covers‑local‑registration, channel‑development, hospital‑access‑and‑reimbursement‑negotiations.
3. Risk & uncertainties
‑ Multiple‑uncertain‑factors: policy‑changes, clinical‑data‑accumulation, exchange‑rate‑volatility.
‑ Large‑scale‑revenue‑growth‑cannot‑be‑realized‑in‑the‑short‑term.
‑ Technical‑certification‑does‑not‑equal‑commercial‑success.
4. Market‑operation outlook
‑ The‑overseas‑neuro‑intervention‑market‑requires‑long‑term‑nurturing.
‑ Profit‑generation‑will‑take‑a‑certain‑period‑of‑time.
IV. Industry Outlook for Domestic Innovative Medical Devices
For the whole industry, special functional metallic materials represented by nickel‑titanium alloy have become a key driver for the competitiveness upgrade of domestic high‑end medical devices. From coronary stents to intracranial interventional devices, domestic enterprises are shifting from exporting low‑end consumables to globalizing original‑innovative high‑end implantable devices. Materials lay the foundation of medical devices. Continuous improvement in nickel‑titanium alloy performance and precision‑processing technologies will support more domestic innovative medical devices to gain access to global markets.
Domestic neurointervention has made remarkable progress in certification. Nevertheless, material development, processing, clinical research and commercialization still require tremendous efforts before large‑scale overseas market penetration can be realized. As China's special‑alloy industry matures, more home‑grown innovative medical devices based on advanced metallic materials are expected to enter the global arena.
Ruihang Group mainly produces titanium products with the complete industry chain,including smelting,forging, straightening,rolling,surface treating,testing process. For any purchasing needs, feel free to contact us at email:Sam.Rui@bjrh-titanium.com