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SI-BONE, Inc. annuncia il raggiungimento di 25.000 impianti iFuse
Date:9/10/2013

ciety for the Advancement of Spine Surgery (ISASS – Società internazionale per l'avanzamento della chirurgia della spina dorsale) ha anche opinato, "ISASS ha di recente rilasciato una dichiarazione di consenso che conclude che la fusione dell'articolazione sacroiliare a ridotta invasività dovrebbe essere coperta dai pagatori, adesso è il suo momento e gli studi dimostrano che è sicura ed efficace, oltre a essere nettamente migliore per il paziente.  Ad esempio, dati recenti dimostrano che la perdita di sangue è pari un decimo di quanto accadeva con le procedure aperte e i pazienti ne escono molto bene."

SI-BONE, Inc. ha ricevuto l'approvazione originale 510(k) a novembre 2008 dalla FDA (Food and Drug Administration – Autorità per alimenti e medicinali) per commercializzare il proprio iFuse Implant System per la fissazione di fratture di ossa lunghe e grandi frammenti ossei della pelvi per condizioni che comprendono rotture dell'articolazione sacroiliache e sacroileite degenerativa, un'ulteriore approvazione è dell'aprile 2011 per la fusione dell'articolazione sacroiliache per condizioni che comprendono rotture dell'articolazione sacroiliaca e la sacroileite degenerativa. Il marchio CE per la commercializzazione in Europa è stato concesso a novembre 2010.

Le pubblicazioni cliniche hanno identificato l'articolazione SI quale fonte di dolore per il 22% di pazienti affetti da algia del basso dorso.(5)  In aggiunta, DePalma et al, Pain Medicine 2011, hanno identificato l'articolazione SI come fonte di dolore per le algie del basso dorso per il 43%, e può arrivare al 61% nei pazienti con fusione post lombare, definita pazienti "con intervento chirurgico non riuscito del dorso".(6)  Le opzioni iniziali per il trattamento dei pazienti af
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Related medicine technology :

1. SI-BONE, Inc. Announces Spring Society Meeting Attendance
2. SI-BONE, Inc. Announces Publication of Postmarket Surveillance Safety Data on First 5,319 Patients Treated with iFuse Implant System
3. 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
4. SI-BONE, Inc. Announces 25,000 iFuse Implant Milestone
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6. Nonin Medical annuncia lo spostamento del Centro Assistenza Clienti dalla Svezia ai Paesi Bassi
7. CryoLife annuncia il primo impianto europeo di HeRO Graft
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