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

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