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Rita公司的HABIB4X癌症手术切除设备获得FDA的许可

【 2005-09-12 发布 】 美迪医讯
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一种新型设备被设计用于在外科手术切除时候的血管组织凝固。该设备已经获得了美国食品药品管理局的许可,并获得了CE标志。

HABIB4X切除设备是由Rita医疗系统公司研制开发的。该设备能够凝固“外科手术切除平面”,从而能够进行快速切开,而出血较少。该公司相信这种技术能够用于肝脏癌症手术,因为该设备被设计将手术过程中的出血和输血降至最少。该设备被设计用于当前的Rita 1500X型发生器射频消融工作平台。

该设备具有下述特征:两极电极设备,用于快速组织消融和凝固;自动Rita 1500X发生器软件升级功能;外科组织切除手术时候出血最少;降低了手术、肿瘤学和癌症领域的费用,包括现在的以及潜在的新客户,这些都与切除方案密切相关。

Rita公司总裁和首席执行官Joseph DeVivo说:“因为我们侧重于癌症治疗,所以我们希望HABIB4X成为我们产品系列的一个强有力的补充。”

Resection Device for Cancer Surgery
 
A new device is designed for use in vascular tissue coagulation during surgical resection. The device has been cleared by the U.S. Food and Drug Administration (FDA) and has also received the CE Mark.

The HABIB4X resection device was developed by Rita Medical Systems, Inc. (Fremont, CA, USA). The device coagulates a “surgical resection plane” to facilitate a fast dissection with limited blood loss. The company believes this technology will be utilized in liver cancer surgeries since it is designed to minimize blood loss and blood transfusion during surgery. The device is designed to work on the current Rita radiofrequency ablation (RFA) platform of 1500X generators.

The device includes the following features: a bipolar electrode device designed for fast tissue ablation and coagulation, automatic operation with Rita 1500X generator software upgrade, minimized blood loss during surgical tissue resection, and reduced costs interest to the surgery, oncology, and cancer communities, which include existing as well as many potential new customers,” observed associated with resection procedures.

“With our focus on cancer therapies, we expect the HABIB4X to be a strong addition to our product portfolio and for it to be of Joseph DeVivo, president and CEO of Rita Medical Systems.

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