סטנט מיטרלי NiTi 5.5mm WT0.3mm
- Diameter: 5.5mm
- עובי דופן: 0.3 מ"מ
- הרכב חומר: סגסוגת ניקל-טיטניום (Ni-Ti)
- Standards Compliance: ISO9001, ISO13485 certified for quality and safety.
Mitral Stent NiTi 5.5mm WT0.3mm – precision self-expanding stent for mitral valve support
The Mitral Stent NiTi 5.5mm WT0.3mm is an advanced, self-expanding medical device meticulously engineered to provide targeted, atraumatic support within the mitral valve annulus. Crafted from premium Nitinol (NiTi) alloy, this innovative stent leverages its inherent superelasticity and shape memory for precise deployment and consistent radial force. Its optimally designed microstructure, featuring a 5.5mm diameter and ultra-thin 0.3mm wall thickness, ensures effective structural integrity, exceptional fatigue resistance, and long-term durability, making it an ideal solution for minimally invasive interventions aimed at restoring mitral valve function and improving cardiac hemodynamics.
תכונות עיקריות:
- Self-Expanding Nitinol (NiTi): Utilizes the unique properties of Nitinol for controlled, atraumatic deployment and sustained radial force, adapting precisely to the complex mitral anatomy without balloon expansion.
- Optimal 5.5mm Diameter: Specifically sized for effective support within the mitral valve, balancing secure fit with minimized impact on native valve function and surrounding structures.
- Ultra-Thin Wall Design (0.3mm): Minimizes the device profile, facilitating easier delivery through catheter systems and reducing the potential for obstruction or interference with leaflet motion.
- Engineered Microstructure: Provides high fatigue resistance and exceptional long-term durability, crucial for devices operating in the dynamic environment of the mitral valve.
- Enhanced Radiopacity: Integrated radiopaque markers ensure clear visualization and precise placement under fluoroscopic guidance, improving procedural safety and accuracy.
- Biocompatible Surface: Promotes healthy endothelialization and significantly reduces thrombogenicity, essential for long-term patient outcomes and minimizing foreign body reactions.
Certification and Standards:
Our Mitral Stent NiTi 5.5mm WT0.3mm 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 rigorous demands for advanced cardiac devices.
Nitinol (NiTi), a nickel-titanium alloy, is renowned for its superelasticity and shape memory, making it a game-changer in medical applications. With a tensile strength of up to 1200 MPa and elastic modulus of 40–75 GPa, nitinol excels in demanding environments./p>
The Mitral Stent NiTi 5.5mm WT0.3mm is engineered for a range of advanced, minimally invasive interventional procedures requiring precise and reliable structural support within the mitral valve complex. Its self-expanding nature, optimal dimensions, and ultra-thin wall design make it particularly suitable for:
- Providing temporary or permanent scaffolding support for valve repair or in specific transcatheter mitral valve interventions.
- Restoring and maintaining the integrity of the mitral annulus in cases of dilatation or dysfunction.
- Addressing mitral valve stenosis by offering a conformable and supportive structure to maintain valve patency.
- Facilitating precise and atraumatic deployment within the cardiac chambers via minimally invasive approaches, reducing patient recovery time.
- Use in investigational applications where a conformable and adaptable frame is required to support or reshape the mitral valve apparatus.
The stent's design ensures highly precise and controlled deployment, contributing significantly to optimal patient outcomes in complex mitral valve scenarios.
- Stent Diameter: 5.5 mm (Self-expanding to nominal diameter)
- Wall Thickness (WT): 0.3 mm
- הרכב חומרים: Medical Grade Nitinol (NiTi) Alloy
- Available Lengths: Offered in a range of standard lengths to accommodate diverse anatomical requirements.
- Radial Force: Optimized to ensure stable apposition and robust support within the mitral annulus without impeding cardiac flow dynamics.
- Fatigue Resistance: Engineered for exceptional long-term durability within the dynamic cardiovascular environment.
- 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.
