The Tycheseal™ Thoracic Stent Graft System (TAA System) is a thoracic endovascular aortic repair (TEVAR) device developed for the minimally invasive treatment of thoracic aortic aneurysms and Stanford Type B aortic dissections. The system is engineered to provide durable sealing, precise deployment, and adaptive conformability in complex thoracic aortic anatomy.
Product Overview
The Tycheseal™ TAA System is designed for:
- Thoracic aortic aneurysm repair
- Stanford Type B aortic dissection treatment
- Descending thoracic aorta endovascular repair (TEVAR)
- Complex thoracic aortic anatomies
The system combines:
- Self-expanding nitinol stent framework
- Multifilament polyester graft material
- Low-profile hydrophilic-coated delivery system
- Precision rotational deployment mechanism
The device is intended to exclude diseased thoracic aortic segments from blood flow while preserving perfusion to critical branch vessels.
Key Features
Designed for Both Aneurysm & Dissection
- Specifically engineered for thoracic aneurysm and Type B dissection repair
- Supports TEVAR procedures in complex descending thoracic anatomy
- Available in bare-stent and non-bare-stent configurations
- Broad size matrix for multiple clinical scenarios
Advanced Sealing Technology
- Dual-segment proximal stent architecture
- Multi-peak waveform design for enhanced apposition
- Designed to reduce Type I endoleak risk
- Improved long-term sealing stability
Conformable Aortic Apposition
- Variable-height stent configuration
- Connector-free structural design
- 360° adaptive vessel conformity
- Enhanced flexibility in tortuous thoracic anatomy
Optimized Distal Protection
- Distal multi-peak stress optimization
- Designed to reduce secondary entry tears (SINE)
- Enhanced distal sealing behavior in dissection repair
Precision Delivery System
- Dual rotational and pull-back deployment control
- Hydrophilic-coated delivery catheter
- Enhanced trackability through iliac and aortic anatomy
- Controlled deployment for precise landing zone placement
Technical Specifications
| Specification | Details |
|---|---|
| Product Type | Thoracic Stent Graft System |
| Procedure Type | TEVAR (Thoracic Endovascular Aortic Repair) |
| Indications | Thoracic aneurysm & Stanford Type B dissection |
| Stent Material | Nitinol |
| Graft Material | Multifilament polyester |
| Configurations | Bare-stent & non-bare-stent |
| Delivery System | Hydrophilic-coated |
| Delivery Profile | 20 Fr OD (30–36 mm sizes) |
| Common Device Sizes | 30–36 mm |
| Deployment Control | Rotational & pull-back release |
| Anatomical Requirement | Proximal landing zone ≥10 mm |
| Registration | CE Certified |
| NMPA Registration | No. 20193130070 |
Clinical Indications
The Tycheseal™ TAA System is indicated for:
- Thoracic aortic aneurysms
- Stanford Type B aortic dissections
- Descending thoracic aortic pathology
- Patients suitable for TEVAR procedures
- Complex thoracic aortic anatomy requiring conformable stent graft technology
Advantages of TEVAR Technology
Compared with open thoracic aortic surgery, TEVAR procedures may provide:
- Reduced surgical trauma
- Lower perioperative morbidity
- Reduced blood loss
- Faster patient recovery
- Shorter ICU and hospital stay
- Minimally invasive femoral access approach
Structural Design Advantages
Dual-Segment Proximal Stent Design
The proximal multi-peak structure is engineered to:
- Improve radial force distribution
- Enhance proximal sealing
- Reduce bird-beaking risk
- Improve wall apposition in angulated anatomy
Connector-Free Architecture
The connector-free stent configuration helps:
- Improve conformability
- Increase flexibility
- Reduce graft kinking
- Adapt to thoracic curvature more effectively
Low-Profile Access System
The 20 Fr delivery profile is designed to:
- Facilitate femoral/iliac access
- Reduce vascular trauma
- Improve deliverability
- Support minimally invasive TEVAR workflow
Procedure Workflow
Typical TEVAR workflow includes:
- Femoral artery access
- Guidewire and sheath placement
- Thoracic angiographic mapping
- Stent graft positioning
- Controlled deployment under fluoroscopy
- Balloon molding if required
- Final angiographic confirmation
The procedure is generally performed in:
- Hybrid operating rooms
- Endovascular suites
- Interventional angiography laboratories
Potential Complications
Potential TEVAR-related complications may include:
- Endoleak
- Stroke
- Spinal cord ischemia
- Access vessel injury
- Graft migration
- Retrograde dissection
- Secondary intervention requirements
Appropriate anatomical assessment and imaging follow-up are essential for long-term outcomes.
Imaging & Post-Procedure Follow-Up
Post-implant surveillance commonly includes:
- CTA (Computed Tomography Angiography)
- Endoleak assessment
- Stent graft integrity monitoring
- Aortic remodeling evaluation
- False lumen thrombosis monitoring in dissections
Long-term imaging follow-up is standard after TEVAR procedures.