Products Overview - Products

Products

Products Overview

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

Aortic valve products

VitaFlow^® System

VitaFlow^®

Launched
Successfully registered in Argentina and Thailand

Alwide^® balloon catheter*

Launched
Successfully registered in Argentina and Thailand

VitaFlow Liberty^® System

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

Mitral valve products

Self-developed replacement product

FIM Study

AltaValve – Replacement product (Partnership with 4C Medical – commercialization rights in China)

Pivotal IDE study in progress

Tricuspid valve products

Self-developed replacement product

Design stage

Replacement product (Partnership with 4C Medical )

Design stage

Procedural accessories

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

AccuSniper^TM double-layer balloon catheter

Received NMPA approval

Alpass^® catheter sheath II

NMPA Registration in progress

Left Atrial Appendage products

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

China status

Global status

Major Progress during the Reporting Period

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