To seize immense market opportunities and address unmet structural heart disease medical needs, the Company has comprehensively laid out a strategic pipeline in both valvular and non-valvular areas of structural heart disease,covering a strong product portfolio including transcatheter aortic valves, left atrial appendage closure, transcatheter mitral valves, transcatheter tricuspid valves, and surgical accessories.
Product
Pre-clinical
Clinical trial
Registration
VitaFlow®
Launched
Successfully registered in Argentina and Thailand
Alwide® balloon catheter*
Launched
Successfully registered in Argentina and Thailand
VitaFlow Liberty® (Retrievable)
Launched
Received CE Mark, registered in Argentina, Colombia,
Thailand, Russia, Indonesia, HKSAR, Chili and Saudi Arabia
Registration in emerging markets in progress
Angelguide®
tip-preshaped super stiff guidewire*
Launched
Successfully registered in Argentina, Colombia and Brazil
VitaFlow Liberty® Flex (Steerable delivery system)
Received NMPA approval @ Dec. 2024
VitaFlow® IV (Lower profile, better durability and hydrodynamic properties)
Design stage
Self- developed AR product (New anti-calcification technology)
Design stage
Self-developed replacement product
FIM Study
AltaValve – Replacement product (Partnership with 4C Medical – commercialization rights in China)
Pivotal IDE study in progress
Self-developed replacement product
Design stage
Replacement product (Partnership with 4C Medical )
Design stage
Alwide® Plus balloon catheter
Launched
Successfully registered in Argentina, Colombia, Brazil,
Thailand, Russia, Saudi Arabia, Indonesia and HKSAR
CE Marking registration and registration
in emerging markets in progress
AccuSniperTM double-layer balloon catheter
Received NMPA approval
Alpass® catheter sheath II
NMPA Registration in progress
AnchorMan® Left Atrial Appendage Access System
Received NMPA approval
Received CE mark @ Nov. 2024
AnchorMan® Left Atrial Appendage Closure System
Received NMPA approval
Received CE mark @ Feb. 2025
New Gen. AnchorMan® Left Atrial Appendage Access System (steerable)
Design stage
New Gen. AnchorMan® Left Atrial Appendage Closure System
Design stage
Among our product candidates, these devices are exempted from clinical trial requirements in accordance with the Catalogue of Medical Device Exempted from Clinical Trials promulgated by the NMPA, as amended
These procedural accessories are registered and commercialized offered as part of VitaFlow® or VitaFlow Liberty® system and are not registered as standalone product in China
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