Innovative design redefines treatment of vessel stenosis in hemodialysis patients.
Merit Medical Systems has gained FDA premarket approval for its Wrapsody cell-impermeable endoprosthesis, setting the stage for a 2025 U.S. launch. The device introduces cutting-edge technology to improve long-term vessel patency in dialysis patients, addressing limitations of traditional covered stents.
Key Features of Wrapsody
- Nitinol stent frame: Provides enhanced radial force and resistance to compression.
- Three-layer PTFE covering:
- Inner layer: Minimizes platelet and fibrin formation.
- Middle layer: Prevents tissue migration.
- Outer layer: Ensures durability and reduces vessel wall stress.
This unique design targets stenosis in AV fistulas and grafts, aiming to reduce reinterventions and enhance patient outcomes.
Expert Validation
Dr. Mahmood K. Razavi of St. Joseph Heart and Vascular Center endorsed the device, stating:
“Wrapsody’s high patency rates position it as a potential new standard of care for hemodialysis patients, surpassing existing options.”
A Decade of Dedication
The Wrapsody device represents a milestone in Merit Medical’s mission to advance dialysis care. Fred P. Lampropoulos, CEO, emphasized the significance of this achievement:
“We’re proud to deliver a solution that demonstrates the highest efficacy and transforms patient care.”
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