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SI-BONE, Inc. annuncia la pubblicazione dei dati sulla sicurezza della sorveglianza post-commercializzazione per i primi 5.319 pazienti trattati con il sistema di impianto iFuse Implant System
Date:6/5/2013

SAN JOSE, California, 5 giugno 2013 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), una società di dispositivi medicali pioniera nell'uso di dispositivi chirurgici a ridotta invasività (MIS) per la fusione dell'articolazione (SI) sacriliaca, ha annunciato oggi la pubblicazione dei dati sulla sicurezza della sorveglianza post-commercializzazione di iFuse Implant System's® per i primi 5.319 pazienti trattati.  Lo studio dal titolo: Analysis of the postmarket complaints database for the iFuse SI Joint Fusion System: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption, è stato pubblicato in Medical Devices: Evidence and Research il 28 maggio 2013.  Lo studio era mirato a fornire un'analisi delle lamentele sulla sorveglianza post-commercializzazione tramite la valutazione del database delle lamentele post-commercializzazione di SI-BONE .  L'analisi, che copre un periodo di 4 anni, dall'aprile 2009 al gennaio 2013 e comprende 5.319 pazienti, ha rivelato un tasso di lamentele complessivo post-commercializzazione del 3,8% che comprende un tasso totale di revisione dell'1,8% e un tasso di revisione tardiva postoperatoria dello 0,6%.  Le revisioni nel periodo postoperatorio tardivo sono state eseguite per trattare la ricorrenza della sintomatologia o per dolore persistente di eziologia non determinata in media a 279 giorni dopo l'operazione.1  Questi tassi sono coerenti con serie di casi pubblicati in precedenza di iFuse Implant System che segnalavano a 1-2 anni tassi di revisione successivi al trattamento dall'8% allo 0%.2,3    "Siamo estremamente orgoglioso della sicurezza e dell'efficacia clinica dimostrata dai chirurghi con la procedura the iFuse.  Il nostro obiettivo centrale come società è la sicurezza dei pazienti e un'efficacia della pr
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