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Il dispositivo LT-300 LumiThera per la cura della degenerazione maculare avanzata secca riceve il marchio CE
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News provided by

LumiThera Inc.

Jun 25, 2018, 02:47 ET

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SEATTLE, 25 giugno 2018 /PRNewswire/ -- LumiThera Inc., una società per dispositivi medicali commerciali impegnata nello sviluppo di terapie non invasive per la fotobiomodulazione (PBM) per disturbi e patologie dell'occhio, ha annunciato di avere ricevuto il marchio CE per l'Unione Europea (UE) per la cura della degenerazione maculare secca correlata all'età (AMD) utilizzando il proprio sistema di emissione luminosa LT-300.

LumiThera LT-300 Light Delivery System (PRNewsfoto/LumiThera Inc.)
LumiThera LT-300 Light Delivery System (PRNewsfoto/LumiThera Inc.)

Il marchio "CE" è l'abbreviazione di Conformité Européenne, che significa Conformità Europea. Il marchio CE è una certificazione che indica la conformità con le direttive per la protezione di salute, sicurezza e ambiente per i prodotti venduti nello Spazio Economico Europeo (SEE).

"Il marchio CE consente a LumiThera di iniziare la commercializzazione nei 28 stati membri della UE e coincide con l'avvio dello Studio Clinico LIGHTSITE II in siti Europei selezionati nei prossimi mesi," ha dichiarato Clark Tedford, Ph.D., Presidente e Amministratore Delegato di LumiThera. "Siamo davvero molto contenti di poter offrire ai pazienti un intervento clinico sicuro ed efficace a partire dallo stadio iniziale per la degenerazione maculare avanzata secca."

"È davvero molto entusiasmante seguire lo sviluppo del trattamento con fotobiomodulazione per i pazienti affetti da degenerazione maculare avanzata secca," ha dichiarato Samuel Markowitz, M.D., Dipartimento di Oftamologia e Scienze della Visione, Università di Toronto. "Questi pazienti possono contare solo su un numero limitato di scelte e la perdita della visione centrale è un fatto estremamente disabilitante per la qualità della loro vita. Il precedente Studio Clinico LIGHTSITE I ha dimostrato che la terapia con fotobiomodulazione è stata estremamente efficace nei pazienti affetti da degenerazione maculare avanzata secca se curata nei primi stadi. Si è anche visto che è necessario somministrare altri trattamenti a intervalli programmati per poter conservare i benefici clinici."

"La fotobiomodulazione può cambiare il modo con cui pensiamo alle cure per la degenerazione maculare avanzata secca," ha dichiarato il Dott. Robert Devenyi, Oftalmologo Capo e Direttore dei Servizi per la Retina, UHN, Università di Toronto. "Fino a questo momento ci siamo limitati ad aspettare e guardare i pazienti mentre perdevano la lor vista, con opzioni terapeutiche limitate. Adesso abbiamo a disposizione una cura in grado di ottenere miglioramenti mirati per quanto riguarda la vista e ridurre un componente chiave della patologia. La fase successiva è confermare i primi risultati della ricerca multi-centro LIGHTSITE II e operare con la comunità medica oftalmologica per definire le prassi migliori per le cure."

Visitate il sito web della Società: http://www.lumithera.com.

Informazioni su LumiThera Inc.
LumiThera è una società per dispositivi medici commerciali impegnata nella cura di persone con problemi agli occhi e patologie che comprendono la degenerazione maculare secca correlata all'età, una delle cause di cecità negli adulti di età superiore a 65 anni. La Società è un'azienda leader nell'uso della Fotobiomodulazione per la cura di disturbi e malattie oculari gravi e croniche. La Società sta sviluppando il sistema per emissione luminosa LT-300 da ufficio, che sarà usato dagli oftalmologi e da altri specialisti degli occhi come cura medica non invasiva.

Il dispositivo ha ricevuto l'autorizzazione per usare il marchio CE da un Organismo Notificato UE come richiesto per poterlo utilizzare commercialmente solo nell'Unione Europea. L'uso di LT-300 non è ancora stato approvato dalla Food & Drug Administration (FDA - Amministrazione per Alimenti e Medicinali) negli Stati Uniti.

2018 LumiThera Inc., Tutti i diritti riservati.

Foto - https://mma.prnewswire.com/media/709536/LumiThera_LT_300.jpg

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http://www.lumithera.com

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