Mitral Stent Ni-Ti 5mm WT0.3mm

קוטר: 5 מ"מ
עובי דופן: 0.3 מ"מ
הרכב חומר: סגסוגת ניקל-טיטניום (Ni-Ti)
הסמכה: ISO9001, ISO13485

בִּמלַאִי

Mitral Stent Ni-Ti 5mm WT0.3mm – innovative self-expanding mitral valve support

The Mitral Stent Ni-Ti 5mm WT0.3mm is a cutting-edge medical device engineered to provide advanced support for the mitral valve. Utilizing a precisely constructed Nitinol (Ni-Ti) microstructure, this self-expanding stent offers robust and adaptable reinforcement within the complex anatomy of the mitral annulus. Its ultra-thin wall design (WT0.3mm) and optimized radial force minimize interference while ensuring excellent apposition, making it an ideal and innovative solution for intricate mitral valve interventions.

תכונות עיקריות:

Self-Expanding Nitinol: Provides exceptional shape memory and superelasticity for accurate deployment and consistent radial force.
Ultra-Thin Walled Design (WT0.3mm): Minimizes profile for smoother delivery and reduces potential for flow obstruction or anatomical interference.
Optimized Microstructure: Ensures high fatigue resistance and long-term durability in the dynamic cardiac environment.
Radiopaque Markers: Facilitate clear visualization and precise placement under fluoroscopic guidance.
Biocompatible Surface: Promotes healthy endothelialization and significantly reduces thrombogenicity.

Certification and Standards:

Our Mitral Stent Ni-Ti 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.

חומרים

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.

בַּקָשָׁה The Mitral Stent Ni-Ti 5mm WT0.3mm is primarily indicated for use in interventional cardiology procedures focused on the treatment of mitral valvular diseases. Its self-expanding design and finely tuned microstructure make it exceptionally well-suited for a variety of interventions requiring stable and sustained support within the complex mitral anatomy. Potential applications include, but are not limited to:

Transcatheter mitral valve repair procedures, including annuloplasty support.
Reinforcement or stabilization of native mitral valve structures.
Addressing mitral valve stenosis or regurgitation through structural support.
Procedures necessitating precise and atraumatic deployment within the cardiac chambers via minimally invasive approaches.

מפרט טכני

Stent Diameter: 5.0 mm (Self-expanding to nominal diameter)
Wall Thickness (WT): 0.3 mm
Material: Medical Grade Nitinol (Ni-Ti)
Available Lengths: Offered in a range of standard lengths to accommodate diverse anatomical requirements.
Radial Force: Optimized to ensure stable apposition without impeding cardiac flow dynamics.
Fatigue Resistance: Engineered for exceptional long-term durability within the challenging 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.