Zhicheng Medical Technology (Jiaxing) Co., Ltd. announced that its self‑developed ReachTact Transcatheter Aortic Valve Replacement (TAVR) Surgical Assistance System has entered the National Medical Products Administration’s (NMPA) Innovative Medical Device Special Review Pathway, becoming the first TAVR robotic system in China’s structural heart disease field to achieve this status.
Regulatory Milestone
Item
Details
Entry Date
15 Dec 2025
Pathway
NMPA Innovative Medical Device Special Review
Product
ReachTact TAVR Surgical Assistance System
Significance
First TAVR robotic system in China to enter the program
Expected Benefit
Expedited review and approval process; potential for 3‑year market exclusivity
Launch Timeline
2027‑2028 (pending successful review)
Product Innovation & Technical Features
Feature
ReachTact System
Clinical Advantage
Control System
Master‑slave robotic control
Surgeon operates from radiation‑shielded environment
Precision
Sub‑millimeter accuracy
Stable grasp of ultra‑stiff guidewires and devices
Haptic Feedback
Low‑latency force feedback
Shortens learning curve; ensures patient safety
Surgical Team
Single‑person synchronous control
Reduces team size and coordination complexity
Design
Bionic, natural interactive handle
Replicates traditional TAVR push‑pull/rotation techniques
Future Integration
Compatible with 5G for remote surgery
Enables decentralization of high‑quality care
Market Opportunity
Metric
Value
Context
China TAVR Market Size
¥8‑10 billion (≈ US$1.1‑1.4 B) (2025)
Growing at 25‑30% CAGR
Annual TAVR Procedures
~10,000 (2024)
Projected to reach 50,000 by 2030
Robotic Penetration
<5% of TAVR procedures
High growth potential with innovation pathway incentives
ReachTact Peak Sales
¥1.2‑1.8 billion (≈ US$170‑250 M) by 2032
15‑20% share of robotic‑assisted TAVR segment
Competitive Moat
First‑mover in China; proprietary master‑slave + haptic tech
3‑year NMPA innovation exclusivity
Strategic Implications
For Zhicheng:Innovation pathway entry validates platform technology; positions company as leader in structural heart robotics; potential for global expansion via 5G remote capabilities.
For Physicians:Radiation shielding reduces occupational exposure; haptic feedback and bionic design shorten learning curve for young surgeons; sub‑millimeter precision enhances procedural safety.
For Patients:Reduced surgical team size may lower infection risk; remote surgery potential democratizes access to high‑volume TAVR centers; precision may improve valve positioning and reduce paravalvular leak.
Forward‑Looking Statements This brief contains forward‑looking statements regarding ReachTact’s review timeline, market penetration, and commercial rollout. Actual results may differ due to regulatory feedback, competitive responses, or technology adoption rates.-Fineline Info & Tech
By Fineline Cube 