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Rapid Medical用于治疗血管痉挛的器械获得FDA突破性器械认证

2022-02-17 国际文传 网络

Comaneci™可暂时扩张血管——被认定为治疗危及生命疾病的新型器械

领先的先进神经血管器械开发商Rapid Medical今天宣布,其用于促进出血性卒中后脑血管痉挛治疗的Comaneci™栓塞辅助器械获得FDA突破性认证。血管痉挛是一种严重的并发症和主要的致残病因。美国食品和药物管理局(FDA)的突破性器械项目旨在让患者更及时地获得新技术(如Comaneci),为危及生命或不可逆转的致残性人类疾患和病况提供更有效的治疗。 

宾夕法尼亚大学神经外科医生Brian Jankowitz, MD评论道:“我们所需要的,是向患者提供更好的解决方案——尚无研究显示哪种单一疗法对症状性血管痉挛治疗是一贯安全和有效的。Comaneci是首款凭借可调式直径/径向力向脑部提供联合治疗的器械,可降低血管损伤的风险。” 

Comaneci已在欧洲上市,用于干预血管痉挛,且正在显示出很有前景的表现。一项包括30例患者的多中心回顾性分析显示,97%的患者血管开口增幅至少达25%,80%的患者增幅达50%或以上1。此外,全球使用Comaneci的手术已超过一万台,用以辅助进行宽颈颅内动脉瘤的弹簧圈栓塞手术。Comaneci拥有可调节的直径、低调置放和卓越的可视性,吸引了全球医生对Comaneci的需求。作为一款临时器械,它提供的治疗方式无需将永久性器械植入脑部。 

脑血管痉挛是一种蛛网膜下腔出血的严重并发症。此类痉挛可导致脑血管狭窄、血流量降低并导致脑组织死亡。该疾病发生于70%的患者中,并导致多达30%的患者神经功能恶化2。 

Rapid Medical美洲区总裁James Romero表示:“此次突破性认证将有助于加快Comaneci上市,有望向上述疾病患者提供更安全的选择,同时也彰显出我们努力开创各类工具,向医生提供更好的操控性,并为患者带来更多量身定制的治疗选择。” 

 

1 来自Rapid Medical位于德国、西班牙、瑞士、法国和美国的多个中心的存档数据。  

2 Shaikh el at; Treatment of cerebral vasospasm secondary to subarachnoid hemorrhage utilizing the Comaneci device. International Neuroradiology, June 2020(Shaikh等;使用Comaneci器械治疗蛛网膜下腔出血继发的脑血管痉挛。《国际神经放射学》,2020年6月)  

 

Comaneci是首款能够帮助医生监测血管扩张、应用增量调节并通过联合治疗加强治疗的器械。凭借这种前所未有的操控性,Comaneci获得了FDA突破性器械认证,其表现优于现有技术,可提高脑血管痉挛治疗中的安全性和有效性。(照片:美国商业资讯)

Comaneci是首款能够帮助医生监测血管扩张、应用增量调节并通过联合治疗加强治疗的器械。凭借这种前所未有的操控性,Comaneci获得了FDA突破性器械认证,其表现优于现有技术,可提高脑血管痉挛治疗中的安全性和有效性。(照片:美国商业资讯)

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    2022-09-13 jeanqiuqiu
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    2022-02-19 apoenzyme
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    2022-02-19 海豹
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