VAS HERO Neurovascular Interventional Robot
VAS HERO achieved regulatory history in March 2023 as the first vascular interventional surgical robot approved by China’s NMPA—and simultaneously the first neurovascular interventional robot approved by any regulatory authority worldwide. Developed by VAS Medical, the system enables physicians to perform cerebral angiography procedures from a radiation-shielded workstation while robotic arms execute precise catheter and guidewire manipulations at the patient bedside.
Product Overview
The VAS HERO system addresses two persistent challenges in neurovascular interventional procedures: cumulative radiation exposure to physicians and the physical demands of manual catheter manipulation. By separating the operator from the radiation field while maintaining precise procedural control, VAS HERO offers a fundamental shift in how cerebrovascular diagnostic procedures can be performed.
Unlike cardiac interventional robots that focus on coronary vessels, VAS HERO targets the cerebrovascular anatomy—navigating the tortuous pathways from femoral access through the aortic arch and carotid arteries to intracranial vessels. This anatomical complexity requires specialized control algorithms and catheter handling capabilities distinct from coronary applications.
The system represents the commercial culmination of research conducted under China’s National Key R&D Program, with clinical development led by neurointerventional specialists at Beijing Tiantan Hospital.
Key Features
Designed for diagnostic cerebral angiography, VAS HERO manipulates both catheter and guidewire simultaneously from a radiation-shielded console, achieving 100% procedural success in a 260-subject trial.
- Complete Workflow Automation: Performs full cerebral angiography procedures rather than isolated procedural steps, from catheter introduction through selective vessel cannulation and contrast injection
- Radiation Isolation: Surgeon operates from shielded console positioned outside the primary radiation beam, eliminating cumulative dose exposure during fluoroscopy-guided procedures
- Dual-Device Control: Simultaneous manipulation of both diagnostic catheter and guidewire through coordinated robotic mechanisms
- Force Transmission: Tactile feedback system conveys resistance and tissue interaction to the operator console
- Sterile Barrier Design: Non-contact transmission mechanisms maintain sterility between robotic components and procedural field
Technical Specifications
With a master-slave architecture and NMPA registration number 国械注准20233010311, VAS HERO became the first neurovascular interventional robot approved by any regulatory authority worldwide.
| Parameter | Specification |
|---|---|
| System Configuration | Master-slave architecture |
| Components | Surgical operation arm, control cabinet, physician console, workstation, foot switch, power supply, disposable accessories |
| Disposable Elements | Catheter holder, guidewire holder, catheter auxiliary components |
| Control Interface | Seated ergonomic console with hand controllers |
| Imaging Integration | Compatible with standard angiography/fluoroscopy systems |
| Regulatory Classification | NMPA Class III Medical Device |
Clinical Applications
VAS HERO is currently approved for diagnostic cerebral angiography—the gold standard imaging procedure for evaluating cerebrovascular pathology. Specific clinical indications include:
- Percutaneous intracranial cerebral angiography for diagnostic evaluation
- Selective catheterization of cerebral vessels for contrast injection
- Pre-procedural mapping for planned neurovascular interventions
- Evaluation of cerebrovascular malformations, aneurysms, and stenoses
The approval covers the delivery and withdrawal of angiography catheters and guidewires under fluoroscopic guidance. Therapeutic interventions such as coil embolization or stent placement are not included in the current approved indications but represent potential future expansion areas.
Clinical Evidence
The pivotal multicenter clinical trial enrolled 260 subjects across three hospitals:
| Institution | Role |
|---|---|
| Beijing Chaoyang Hospital | Lead site |
| First Hospital of Hebei Medical University | Participating site |
| Shanxi Provincial People’s Hospital | Participating site |
Trial Results:
- Procedural success rate: 100%
- Postoperative complications: None reported
- This represented the largest neurovascular robot clinical study internationally at time of completion
The study demonstrated that robotic-assisted angiography could achieve equivalent procedural outcomes to manual techniques while eliminating physician radiation exposure during the procedure.
Regulatory Status
| Region | Status | Date | Registration Number |
|---|---|---|---|
| China (NMPA) | Approved | 2023-03 | 国械注准20233010311 |
| Europe (CE) | Not Applied | - | - |
| USA (FDA) | Not Applied | - | - |
VAS HERO achieved NMPA approval as the first-in-class product for vascular interventional robots in China. The approval was granted through standard review pathways rather than the innovation priority review track.
Operational Requirements
Per NMPA approval specifications, VAS HERO operation requires:
- Physician qualification: Associate chief physician level or above
- Mandatory completion of manufacturer training program
- Use within qualified medical institutions equipped with standard angiography facilities
Frequently Asked Questions
What makes VAS HERO different from cardiac interventional robots?
VAS HERO is specifically designed for neurovascular anatomy, which presents distinct challenges compared to coronary intervention. Cerebral vessels require navigation through the aortic arch and carotid arteries with their characteristic tortuosity, demanding different catheter control characteristics than coronary robots optimized for radial or femoral-to-coronary pathways.
Can VAS HERO perform therapeutic procedures like coiling or stenting?
The current NMPA approval covers diagnostic cerebral angiography only. Therapeutic capabilities including aneurysm coiling, stent placement, and thrombectomy are not included in the approved indications. VAS Medical has indicated plans to expand indications to therapeutic applications in future product iterations.
What are the radiation protection benefits?
During conventional cerebral angiography, physicians stand adjacent to the patient throughout the procedure, accumulating radiation exposure from fluoroscopic imaging. VAS HERO enables the surgeon to control the procedure from a shielded console positioned away from the primary beam, effectively eliminating occupational radiation exposure for these procedures.
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Sources
Publicly available references used for the data on this page. See data methodology for verification standards.
