The On | 合法醫療器材資訊網
由RMoidl著作·2002·被引用62次—Background:MulticenterclinicaltrialswereconductedinEuropeandNorthAmericatoevaluatetheperformanceoftheOn-Xbileafletheartvalveprosthesis ...
Background: Multicenter clinical trials were conducted in Europe and North America to evaluate the performance of the On-X bileaflet heart valve prosthesis (Medical Carbon Research Institute, Austin, TX).
Methods: A total of 532 patients underwent implantation, 303 for aortic valve replacement (AVR) and 229 for mitral valve replacement (MVR), at 20 centers from September 1996 to July 2001. The study followed the guidelines of the AATS/STS. Mean follow-up was 23 months (total 1024 patient-years; maximum 5 years). Poolability analysis was performed to show the equivalence of the populations.
Results: Patients and results were found to be similar and poolable. Freedom from adverse events at 2 years in the study were as follows: thromboembolism, 96.0% for AVR patients and 96.3% for MVR; thrombosis, 100% for AVR and 100% for MVR; bleeding events, 96.6% for AVR and 95.7% for MVR; and over...
On-X Heart Valves | 合法醫療器材資訊網
On-X Life Technologies | 合法醫療器材資訊網
On-X Heart Prosthetic Heart Valve IFU Rev N | 合法醫療器材資訊網
Instructions for Use - On | 合法醫療器材資訊網
On-X Valve | 合法醫療器材資訊網
The On | 合法醫療器材資訊網
Summary of Safety and Effectiveness Data On | 合法醫療器材資訊網
The On | 合法醫療器材資訊網
The On | 合法醫療器材資訊網
Aortic Valve Replacement | 合法醫療器材資訊網
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