סטנט שסתום Ni-Ti 9.5mm WT0.5mm
- קוטר: 9.5 מ"מ
- עובי דופן: 0.5 מ"מ
- הרכב חומר: סגסוגת ניקל-טיטניום (Ni-Ti)
- הסמכה: ISO9001, ISO13485
Valve Stent Ni-Ti 9.5mm WT0.5mm – advanced self-expanding stent for valvular support
The Valve Stent Ni-Ti 9.5mm WT0.5mm is a cutting-edge medical device meticulously engineered to provide robust and adaptable support within challenging cardiovascular anatomies, specifically designed for valvular applications. Crafted from a high-purity Nitinol (Ni-Ti) alloy, this innovative stent leverages its inherent superelasticity and shape memory to ensure precise, self-expanding deployment and sustained radial force. Its precisely constructed microstructure, featuring a 9.5mm diameter and 0.5mm wall thickness, ensures optimized radial force, exceptional fatigue resistance, and long-term durability, making it an ideal solution for advanced interventional procedures requiring temporary or permanent structural integrity.
תכונות עיקריות:
- Self-Expanding Nitinol (Ni-Ti): Utilizes the shape memory and superelastic properties of Nitinol for precise, atraumatic deployment and consistent radial force, eliminating the need for balloon expansion.
- Optimal 9.5mm Diameter: Specifically designed for effective support in various valvular anatomies and medium-sized vessels, balancing precise fit with minimal obstruction.
- Engineered Microstructure: Provides high fatigue resistance and exceptional long-term durability within dynamic cardiovascular environments, ensuring device longevity.
- Enhanced Radiopacity: Integrated radiopaque markers ensure clear visualization and precise placement under fluoroscopic guidance, enhancing procedural safety and accuracy.
- Biocompatible Surface: Promotes healthy endothelialization and significantly reduces thrombogenicity, crucial for long-term patient outcomes and minimizing foreign body reactions.
- Thin-Wall Design (0.5mm): Minimizes the device’s profile, facilitating easier delivery through catheter systems and reducing potential for obstruction or interference with surrounding structures.
Certification and Standards:
Our Valve Stent Ni-Ti 9.5mm WT0.5mm is manufactured under stringent quality control protocols, adhering to the highest international medical device standards, including ISO 13485:2016 and CE marking requirements. Each device undergoes comprehensive testing to guarantee its safety, performance, and efficacy in clinical applications. Strict adherence to Good Manufacturing Practices (GMP) ensures traceability, purity, and consistency from raw material to finished product, meeting the stringent demands for advanced medical devices.
ניטינול (NiTi), סגסוגת ניקל-טיטניום, ידועה באלסטיותה העל ובזיכרון הצורה שלה, מה שהופך אותה לפורצת דרך ביישומים רפואיים. עם חוזק מתיחה של עד 1200 מגה פסקל ומודול אלסטיות של 40-75 ג'יגה פסקל, ניטינול מצטיין בסביבות תובעניות.
The Valve Stent Ni-Ti 9.5mm WT0.5mm is engineered for a range of advanced interventional procedures requiring precise and reliable structural support within the cardiovascular system, with a particular focus on valvular applications. Its self-expanding nature and optimal dimensions make it suitable for:
- Providing temporary or permanent structural support in mitral valve stenosis or regurgitation as a scaffolding for valve repair or replacement.
- Supporting reconstructed segments within medium-sized arteries or veins to maintain lumen patency.
- Addressing specific cases of vascular stenosis where a controlled and sustained radial force is required.
- Applications necessitating precise and atraumatic deployment within the cardiac chambers or complex vascular anatomies via minimally invasive approaches.
- As a component in investigational transcatheter heart valve (THV) systems requiring an adaptable and robust frame.
The stent’s design ensures precise and controlled deployment, contributing to optimal patient outcomes in complex interventional scenarios.
- Stent Diameter: 9.5 mm (Self-expanding to nominal diameter)
- Wall Thickness (WT): 0.5 mm
- הרכב חומרים: Medical Grade Nitinol (Ni-Ti) Alloy
- Available Lengths: Offered in a range of standard lengths to accommodate diverse anatomical requirements.
- Radial Force: Optimized to ensure stable apposition and robust lumen support without impeding cardiac or vascular flow dynamics.
- Fatigue Resistance: Engineered for exceptional long-term durability within dynamic cardiovascular environments.
- Sterilization Method: EO (Ethylene Oxide) Sterilized.
- Packaging: Individually sterile-packed to ensure integrity for single-use application.
- Compatibility: Fully compatible with conventional delivery systems and endoscopic channels for precise and controlled deployment.
- Radiopacity: Enhanced for superior visualization during fluoroscopic guidance, ensuring accurate placement.
