Tag : AVF

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Concept Medical Inc.的MagicTouch AVF Sirolimus塗層球囊獲得FDA的「突破性醫療器材認證」

Newsemia
佛羅里達州坦帕–(BUSINESS WIRE)–(美國商業資訊)–Concept Medical Inc. (CMI)的MagicTouch AVF獲得美國食品藥品管理局(FDA)的「突破性醫療器材認證」,該器材是一種Sirolimus藥物塗層球囊(DCB)導管,用於腎功能衰竭透析治療中動靜脈瘻管或動靜脈人工瘻管狹窄性病灶的治療。 2019年7月,FDA收到Concept Medical Inc. (CMI)提交的MagicTouch AVF突破性醫療器材認證申報。該突破性醫療器材認證提交的適應症是「MagicTouch Sirolimus塗層球囊導管通過經皮管腔內血管成形術(PTA),用於治療失去功能的本體動靜脈透析瘻管或人工瘻管的狹窄性病灶,在此之前,血管已經過適當準備,狹窄病灶直徑介於4毫米至12毫米,長度最長達100毫米。」FDA在8月28日通知CMI,表示「貴公司組合產品和提交的適應症符合標準,已通過突破性醫療器材認證。」 血液透析是用於處治腎功能衰竭的方法,採用機器將患者的血液輸送至體外的篩檢器(即透析機)。該方法需要開放血管,通常在前臂手術切開血管(即「血管通路」 Source link...
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Samenvatting: Concept Medical Inc. krijgt ‘Breakthrough Device Designation’ van de FDA voor zijn MagicTouch AVF Sirolimus gecoate ballon

Newsemia
TAMPA, Fla.–(BUSINESS WIRE)–Concept Medical Inc. (CMI) heeft van de Amerikaanse Food and Drug Administration (FDA) de “Breakthrough Device Designation” gekregen van de Amerikaanse Food and...
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Concept Medical Inc. Recibió la “Breakthrough Device Designation” de la FDA para el Balón Recubierto con Sirolimus de AVF MagicTouch

Newsemia
TAMPA, Florida–(BUSINESS WIRE)–Concept Medical Inc. (CMI) recibió la “Breakthrough Device Designation” (Designación de dispositivo innovador) de la Administración de Medicamentos y Alimentos (Food and Drug...
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Concept Medical Inc. recebeu a “Breakthrough Device Designation” (Designação de dispositivo inovador) da FDA pelo balão revestido com Sirolimus, MagicTouch AVF

Newsemia
TAMPA, Flórida.–(BUSINESS WIRE)–Concept Medical Inc. (CMI) recebeu a “Breakthrough Device Designation” da Administração de alimentos e medicamentos dos EUA (FDA) pelo MagicTouch AVF, seu cateter...

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