NMPA Approves First Domestic Sirolimus Drug Balloon for Arteriovenous Fistula
On September 10, 2026, the Xinghe AVFTM sirolimus drug balloon for arteriovenous fistula, independently developed by Shanghai Bomai'an Medical Technology (Bomai'an Medical), the peripheral intervention unit incubated by Blue Sail Medical, was officially approved for market launch by the National Medical Products Administration (NMPA).
The product is the first approved sirolimus-class drug balloon for arteriovenous fistula in China, and its launch fills the gap for sirolimus drug balloons in this field.
Why this event matters
The event has a measured impact on 2 industrys. The strongest current signal is positive for Medical Equipment, with intensity 50/100 and 75% confidence over a medium term horizon.
Medical Equipment
- Direction
- positive
- Intensity
- 50
- Confidence
- 75%
- Horizon
- Medium term
Pharmaceuticals
- Direction
- positive
- Intensity
- 40
- Confidence
- 70%
- Horizon
- Medium term
Impact figures are analytical estimates that combine direction, intensity, confidence and event importance. They are not investment advice.