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Boston Scientific annuncia l'ottenimento del marchio CE e i primi impianti dei suoi sistemi quadripolari x4 CRT-D di ultima generazione
Date:1/8/2014

T-D X4 utilizzano batterie con la stessa chimica avanzata della batteria dei dispositivi Boston Scientific usati in questo studio.

In seguito all'ottenimento del marchio CE dei sistemi CRT-D quadripolari X4, Boston Scientific prevede di iniziare uno studio clinico globale per raccogliere ulteriori dati sugli elettrocateteri ACUITY X4 nei pazienti indicati per un CRT-D. Per questo studio prospettico, non randomizzato, osservazionale, Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY X4 (RALLY X4), si prevede l'arruolamento di un massimo di 1.000 pazienti che riceveranno gli elettrocateteri ACUITY X4 in circa 100 centri in 18 Paesi.

"Lo scompenso cardiaco è un importante problema cardiovascolare e i CRT-D possono salvare vite e migliorare la qualità di vita dei pazienti. L'ottenimento del marchio CE per i nostri sistemi innovativi CRT-D quadripolari è un momento davvero epocale in termini di trattamento dei pazienti affetti da scompenso cardiaco e a rischio di arresto cardiaco improvviso", ha affermato Michael Onuscheck, senior vicepresident e presidente, Boston Scientific Europa. "Siamo inoltre lieti di offrire ai medici un sistema CRT-D che possa migliorare in maniera significativa la procedura di impianto."

Il sistema CRT-D quadripolare X4 di Boston Scientific è attualmente approvato per l'uso esclusivo nei Paesi che richiedono il marchio CE. Negli Stati Uniti, il sistema CRT-D quadripolare X4 è un dispositivo sperimentale e non è disponibile in commercio.

Informazioni su Boston Scientific

"Trasformare la vita offrendo soluzioni mediche innovative che migliorano la salute dei pazienti di tutto il mondo". E' questa la missione di Boston Scientific, che, in qualità di leader globale nel settore della tecnologia medica da più di 30 anni, vuole far progredire la scienza a servizio della salute grazie a un'ampia gamma di soluzioni a
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