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
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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