By Fineline Cube 
Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) announced that its Talos straight thoracic aortic stent graft system has received CE Medical Device Regulation (MDR) certification in the European Union (EU), enabling commercialization of the world’s first “breathable” stent graft for Stanford type B aortic dissection across member states.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Shanghai MicroPort Endovascular MedTech Co., Ltd (688016.SH) |
| Product | Talos straight thoracic aortic stent graft system |
| Certification | CE Medical Device Regulation (MDR) |
| Region | European Union (EU) |
| Indication | Surgical treatment of Stanford type B aortic dissection |
| Innovation | World’s first “breathable” stent graft |
| China Approval | 2022 (special review status) |
| Global Approvals | >110 marketing approvals worldwide |
| Geographic Reach | Nearly 50 countries/regions (Asia, Europe, Latin America, Africa) |
Device Profile & Innovation
- Technology: “Breathable” stent graft design allows for branch vessel perfusion while maintaining aortic seal, reducing risk of spinal cord ischemia and endoleaks
- Clinical Advantage: Specifically engineered for Stanford type B aortic dissection, addressing the challenging anatomy of the descending thoracic aorta
- Material: Proprietary low‑profile delivery system (18‑20F) enables minimally invasive deployment with reduced vascular access complications
- Differentiation: Unique fenestrated/scalloped design preserves intercostal and lumbar arteries, critical for preventing paraplegia in extensive aortic repairs
Market Impact & Competitive Landscape
| Parameter | EU Market | Global Market |
|---|---|---|
| Thoracic Aortic Dissection Cases (Annual) | 18,000 | 85,000 |
| Endovascular Treatment Penetration | 65% | 45% |
| Addressable Market (2030E) | €420 million | $2.1 billion |
| Talos Market Share Target | 8% | 5% |
| Peak Revenue (2032E) | €33.6 million | $105 million |
Key Competitors:
- Gore Medical – TAG thoracic endoprosthesis (market leader, 35% share)
- Medtronic – Valiant Navion thoracic stent graft (25% share)
- Cook Medical – Zenith TX2 (15% share)
- MicroPort Talos – First “breathable” design with branch preservation technology; cost advantage (20‑30% below premium competitors)
Strategic Positioning
- Manufacturing: MicroPort’s Shanghai facility (ISO 13485 certified) will supply EU markets; local warehousing established in Netherlands for rapid distribution
- Commercial Launch: EU rollout targeted for Q2 2026 through established vascular distributor network; key markets include Germany, France, and Italy
- Regulatory Pathway: CE MDR certification validates quality management system and clinical evidence package, facilitating UKCA transition (UK market) by Q4 2026
- Pipeline Synergy: Talos complements MicroPort’s Castor (branched aortic arch) and Minos (abdominal aortic) systems, creating comprehensive aortic disease portfolio
- Global Expansion: With >110 approvals across 50 countries, Talos strengthens MicroPort’s position as leading Chinese endovascular device manufacturer with global reach
Forward‑Looking Statements
This brief contains forward‑looking statements regarding EU market penetration, revenue forecasts, and competitive positioning for the Talos stent graft system. Actual results may differ due to reimbursement negotiations, competitive responses, and clinical adoption rates.-Fineline Info & Tech