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Stereotaxis and MicroPort EP Secure NMPA Approval for Magbot Ablation Catheter in China

Stereotaxis and MicroPort EP Secure NMPA Approval for Magbot Ablation Catheter in China

Stereotaxis和微創醫療在中國獲得Magbot消融導管的NMPA批准
Benzinga ·  12/09 20:27

Stereotaxis (NYSE:STXS) and Shanghai MicroPort EP Medtech Co., Ltd. (688351.SH, "MicroPort EP"), today announced that the Magbot Magnetic Navigation Ablation Catheter has received regulatory approval from China's National Medical Products Administration (NMPA).

Stereotaxis(紐交所:STXS)與上海微創醫療EP醫療科技有限公司(688351.SH,"微創醫療EP")今天宣佈,Magbot磁導航消融導管已獲得中國國家醫療產品管理局(NMPA)的監管批准。

The Magbot Catheter is a single-use magnetic saline-irrigated radiofrequency ablation catheter designed and developed by MicroPort EP in collaboration with Stereotaxis. The catheter works exclusively and in tight conjunction with Stereotaxis' robotic systems, including the recently NMPA-approved Genesis RMN, and MicroPort EP's Columbus 3D EP Mapping System.

Magbot導管是一種一次性使用的磁性生理鹽水灌注射頻消融導管,由微創醫療EP與Stereotaxis合作設計和開發。該導管僅與Stereotaxis的機器人系統緊密配合使用,包括最近獲得NMPA批准的Genesis RMN以及微創醫療EP的Columbus 3D EP映射系統。

Magbot incorporates advanced design features that substantially enhance the efficiency, effectiveness, and safety of robotic magnetic catheter ablation. Robotically navigated using low-intensity magnetic fields, the Magbot catheter is able to reach areas of the heart otherwise difficult to access with traditional methods and to maintain precise positioning and stability on cardiac anatomy with millimeter-level accuracy. Full integration with Columbus enables real-time location tracking and 3D cardiac modeling, allowing physicians to accurately record electrocardiographic data and pinpoint lesions for precise diagnosis and treatment of arrhythmias. A unique six-electrode design enhances safety during procedures by offering visibility of the catheter shaft without the need for fluoroscopy. Magbot has been approved by NMPA for the ablation of drug-resistant persistent atrial fibrillation, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia.

Magbot結合了先進的設計特點,顯著提高了機器人磁性導管消融的效率、有效性和安全性。Magbot導管通過低強度的磁場進行機器人導航,能夠到達心臟那些傳統方法難以到達的區域,並以毫米級的精確度維持心臟結構的精確定位和穩定。與Columbus的全面整合實現了實時位置跟蹤和3D心臟建模,使醫生能夠準確記錄心電圖數據並精確識別病竈,以便對心律失常進行準確診斷和治療。獨特的六電極設計在操作過程中增加了安全性,無需熒光透視即可觀察導管軸。Magbot已獲得NMPA批准,用於消融藥物耐藥性持續性房顫、房室結折返性心動過速和房室折返性心動過速。

譯文內容由第三人軟體翻譯。


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