Why Is Boston Scientific Stock Trading Lower On Wednesday?
Why Is Boston Scientific Stock Trading Lower On Wednesday?
SAPIEN valve is sold by On Wednesday, Boston Scientific Corporation (NYSE:BSX) released the results of the primary endpoint of the ACURATE IDE trial of ACURATE neo2 Aortic Valve System for patients with severe, symptomatic aortic stenosis at risk of open-heart surgery.
週三，波士頓科學公司（紐交所：BSX）發佈了ACURATE IDE試驗的主要終點結果，該試驗評估了ACURATE neo2主動脈瓣系統對有嚴重、症狀性主動脈狹窄且存在開心手術風險的患者的效果。
The data were presented at Transcatheter Cardiovascular Therapeutics 2024, the annual scientific symposium of the Cardiovascular Research Foundation.
數據在2024年轉導心血管療法學年會上發佈，這是心血管研究基金會的年度科學研討會。
This randomized trial evaluated the ACURATE neo2 valve, the company's second-generation transcatheter aortic valve replacement (TAVR) technology, versus a pre-defined control valve, either the commercially available SAPIEN valve or the Evolut transcatheter aortic valve system.
這項隨機試驗評估了ACURATE neo2瓣膜，這是公司的第二代經導管主動脈瓣替換（TAVR）技術，與預定義的對照瓣膜進行比較，可以是已商用的SAPIEN瓣膜或Evolut經導管主動脈瓣系統。
SAPIEN valve is sold by Edwards Lifesciences Corporation (NYSE:EW), and Evolut is Medtronic Plc's NYSE: MDT) brand.
SAPIEN瓣膜由愛德華生命科學公司（紐交所：EW）銷售，Evolut是美敦力公司（紐交所：MDT）的品牌。
The composite rate of all-cause mortality, stroke, or rehospitalization at one year was 16.16% in the ACURATE neo2 arm and 9.53% in the control arm, not meeting the prespecified criterion for non-inferiority (the posterior probability for non-inferiority was 77.9%, which is lower than the non-inferiority test threshold of 97.5%).
ACURATE neo2組一年內的複合全因死亡率、中風或再住院率爲16.16%，對照組爲9.53%，未達到非劣效性的預先規定標準（非劣效性的後驗概率爲77.9%，低於非劣效性檢驗閾值97.5%）。
"This trial is the largest randomized comparison of TAVR platforms and was conducted over four years, including during a global pandemic that introduced complexities for enrollment," said Michael Reardon, co-principal investigator of the ACURATE IDE trial.
「這項試驗是TAVR平台最大的隨機比較，歷時四年進行，包括在引入招募複雜性的全球大流行期間，」ACURATE IDE試驗的聯合首席研究員邁克爾·雷爾登說。
The company also presented data from a post-hoc analysis to identify and evaluate expanded and under-expanded ACURATE neo2 valve frames within the ACURATE IDE trial.
公司還展示了ACURATE IDE試驗中篩選和評估ACURATE neo2瓣膜框架擴張的後續分析數據。
The company reviewed key procedural factors, including pre-and post-dilation, which help prepare for, enable, and confirm proper valve expansion during the procedure.
公司審查了關鍵的程序因素，包括術前和術後擴張，這有助於準備、啓用並確認程序中閥膜的正確擴張。
Following this review, an assessment of implant quality for the ACURATE neo2 valve was initiated. The assessment highlighted that approximately 20% of the valves were under-expanded.
在進行此次審查後，對ACURATE neo2瓣膜的植入質量進行了評估。評估表明，約有20%的瓣膜未充分擴張。
Data from the assessment also demonstrated that the rate of death, stroke, or rehospitalization at one year was similar between the ACURATE neo2 expanded group and the control group.
評估數據還顯示，ACURATE neo2擴張組和對照組在一年內死亡、中風或重新入院率相似。
Boston Scientific continues to work closely with the U.S. Food and Drug Administration on the regulatory strategy for approval of the ACURATE valve platform in the U.S.
波士頓科學公司與美國食品和藥物管理局密切合作，就ACURATE瓣膜平台在美國獲得批准的監管策略繼續努力。
The ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are approved in Europe.
ACURATE neo2主動脈瓣系統和ACURATE Prime主動脈瓣系統已獲得歐洲批准。
In the U.S., the ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are investigational devices.
在美國，ACURATE neo2主動脈瓣系統和ACURATE Prime主動脈瓣系統是調查性設備。
Price Action: BSX stock is down 1.66% at $83.16 at last check Wednesday.
股價走勢：BSX股價在週三最新檢查時下跌了1.66%，報83.16美元。
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譯文內容由第三人軟體翻譯。
