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CartiHeal:用于治疗关节面损伤的Agili-C植入物通过FDA IDE审批

2016-12-22 佚名 CartiHeal (2009) Ltd

用于治疗软骨和骨软骨缺损的无细胞现成植入物的开发商CartiHeal (2009) Ltd.今天宣布,该公司为 Agili-C™ 植入物提交的研究用器械豁免(IDE)申请获得 FDA 批准,之后将申请上市前批准(PMA)。

-CartiHeal宣布用于治疗关节面损伤的Agili-C植入物通过FDA IDE审批

以色列卡法萨巴2016年12月22日电 /美通社/ --

PMA关键性研究将于2017年开始

用于治疗软骨和骨软骨缺损的无细胞现成植入物的开发商CartiHeal (2009) Ltd.今天宣布,该公司为 Agili-C™ 植入物提交的研究用器械豁免(IDE)申请获得 FDA 批准,之后将申请上市前批准(PMA)。

(图标:http://mma.prnewswire.com/media/451231/CartiHeal_Logo.jpg )

为期两年的关键性研究将涉及美国境内外中心的至少250名患者。该研究旨在证明 Agili-C™ 植入物在治疗骨关节炎和非退行性病变的膝盖软骨/骨软骨缺损方面强于标准治疗方法(微骨折术和清创术),是首项获得批准的关于单一植入物广泛适应症的研究。

该研究是一项前瞻性、多中心、开放标签、随机对照试验,涉及同一关节的3种损伤,可治疗总面积为1-7平方厘米。

在欧洲和以色列各大中心进行的一系列临床试验中,Agili-C™ 被植入220多名膝盖、脚踝和拇趾软骨损伤患者体内。在这些试验中,该获得CE认证的植入物被用于治疗骨关节炎患者的各种软骨损伤,从单一局灶性损伤到多发性大面积缺损。

试验结果证明了 Agili-C™ 在软骨再生和软骨下骨重建以及疼痛和症状缓解方面的潜力。

国际软骨修复学会(ICRS)会长、CartiHeal 临床咨询委员会成员 Ken Zaslav 博士解释说:“迄今为止所进行的关键性研究总是专注于极少数患者的小面积、局灶性和孤立性软骨损伤,不代表现实生活中的大多数情况。基于 Agili-C™ 植入物稳定的临床数据,FDA首次批准将其用于治疗膝盖骨关节炎,从单一局灶性缺损到多发性缺损,其适应症十分广泛,我们外科医生每天都会接诊到此类患者。此外,这项激动人心的研究还将在一个治疗群组中比较两种控制模式:微骨折术治疗局灶性损伤,清创术治疗骨关节炎患者。”

CartiHeal 创始人兼首席执行官 Nir Altschuler 表示:“过去几年,我们在各大中心进行了一系列临床研究,以了解哪些患者能受益于 Agili-C™ 植入物。我们与临床咨询委员会联手设计了一套以可能受益于这种植入物的广大患者为目标的研究方案。我们很高兴FDA批准了我们的研究设计,并且相信 Agili-C™ 植入物将成为治疗多种软骨损伤的理想方案。造福那些希望免受疼痛困扰、回归积极生活状态,而且目前没有其他好选择的患者。”

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    2016-12-24 zhaojie88
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    2016-12-24 jiyangfei

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