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Merit Medical's WRAPSODY WAVE Trial Demonstrates Patency Vs. Standard Of Care In AV Fistula Patients

Merit Medical's WRAPSODY WAVE Trial Demonstrates Patency Vs. Standard Of Care In AV Fistula Patients

美敦力醫療的WRAPSODY WAVE試驗顯示與AV瘻患者的標準護理相比具有通暢性
Benzinga ·  09/16 20:42

Merit Medical Systems, Inc. (NASDAQ:MMSI), a global leader of healthcare technology, today announced positive 6-month findings from the randomized arteriovenous (AV) fistula arm of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The data were shown at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) during a FIRST@CIRSE presentation.

全球領先的醫療科技公司美泰醫療系統公司(納斯達克:MMSI)今天宣佈,其WRAPSODY動脈-靜脈(AV)瘻手臂隨機試驗的6個月結果呈現積極態勢。這些數據在歐洲心血管和介入放射學協會(CIRSE)的FIRST@CIRSE報告會上展示。

WRAPSODY is a cell-impermeable endoprosthesis which is intended to extend long-term vessel patency in dialysis patients. Many patients undergoing dialysis rely on a vascular access site created in the arm called an AV fistula. The maintenance of adequate blood flow through this site is crucial for patient survival.

WRAPSODY是一種不能透過電芯的內支架,旨在延長透析患者長期的血管通暢性。許多接受透析的患者依賴於在手臂上創建的一種AV瘻血管通路。通過該通路維持足夠的血流對患者的生存至關重要。

The AV fistula arm of the WAVE trial enrolled 245 patients at 43 sites. Patients were randomized 1:1 to WRAPSODY or percutaneous transluminal angioplasty (PTA). Target lesion primary patency in patients treated with WRAPSODY was 27 percentage points higher than patients in the PTA cohort (89.8% vs. 62.8%, p<0.0001).1 The proportion of patients who experienced an adverse event was similar between cohorts.2

WAVE試驗的AV瘻部分在43個研究地點招募了245名患者。患者被隨機分配到WRAPSODY或經皮透支性血管成形術(PTA)的2組:1組。通過WRAPSODY治療的患者的靶病變初級通暢性比PTA組的患者高出27個百分點(89.8% vs. 62.8%,p

譯文內容由第三人軟體翻譯。


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