By Fineline Cube 
Lifetech Scientific Corporation (HKG: 1302) announced that China’s National Medical Products Administration (NMPA) has granted market approval for its G‑iliac Pro iliac artery covered stent system, a next‑generation device for endovascular reconstruction of the internal iliac artery during complex aortic aneurysm repair.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Type | Full market approval |
| Product | G‑iliac Pro iliac artery covered stent system |
| Indication | Endovascular treatment of abdominal aortic aneurysm with iliac artery involvement; reconstruction of internal iliac artery |
| Approval Date | 5 Nov 2025 |
| Predicate Device | G‑iliac iliac artery bifurcated stent (NMPA‑approved 2021) |
Device Profile & Clinical Advancement
- Technology: Iliac branch device (IBD) designed to preserve internal iliac artery flow during EVAR, preventing ischemic complications.
- Key Improvements vs. G‑iliac: 18 % lower profile (14 F delivery system), hydrophilic coating for smoother navigation, and enhanced radio‑opaque markers for sub‑millimeter positioning accuracy.
- Clinical Evidence: Prospective multicenter trial (n = 156) demonstrated 97 % technical success, 98 % 12‑month primary patency, and 0 % type III endoleaks. Notably, gluteal claudication rate was 3 % vs. 22 % historically reported with iliac artery embolization.
- Guideline Alignment: Complies with SVS, ESVS, and Chinese Vascular Surgery Society consensus recommending at least one internal iliac artery preservation during EVAR.
Market Landscape & Revenue Outlook
| Parameter | 2025E | 2026E | 2027E |
|---|---|---|---|
| China AAA Cases | 85,000 | 90,000 | 95,000 |
| IBD‑Eligible Cases | 18,000 | 19,500 | 21,000 |
| G‑iliac Pro Market Share Target | 0 % | 35 % | 45 % |
| Estimated ASP | – | ¥85,000 | ¥80,000 |
| Revenue Forecast | – | ¥579 million | ¥756 million |
- Competitive Environment: G‑iliac Pro enters a market dominated by Medtronic’s Valiant Navion™ and Gore’s Excluder® IBE. However, as the only domestically‑manufactured, ready‑to‑use IBD with full NMPA approval, Lifetech benefits from procurement preferences under China’s “Buy China” policies.
- Hospital Adoption: Device has completed pre‑approval training at 24 tertiary vascular centers; first commercial implants scheduled for Q1 2026.
- Health Economics: Preserving pelvic perfusion reduces post‑operative complication‑related costs by an estimated ¥40,000 per patient, strengthening the value proposition to payers.
Strategic Positioning
- Pipeline Synergy: G‑iliac Pro complements Lifetech’s A‑Force abdominal stent graft system, enabling a complete off‑the‑shelf solution for complex aorto‑iliac disease.
- IP Portfolio: 18 granted patents covering the dual‑component delivery mechanism and branch stent geometry.
- Export Potential: CE‑mark application planned for 2026, targeting EMEA markets where IBD adoption is accelerating.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding market penetration, revenue forecasts, and regulatory expansion for G‑iliac Pro. Actual results may differ due to competitive responses, pricing pressures, and evolving clinical guidelines.-Fineline Info & Tech