share_log

Stereotaxis Receives European CE Mark Approval For MAGiC Ablation Catheter, Enhancing Robotics In Electrophysiology With Advanced Navigation, Improved Data, And Low-Flow Cooling Benefits

Stereotaxis Receives European CE Mark Approval For MAGiC Ablation Catheter, Enhancing Robotics In Electrophysiology With Advanced Navigation, Improved Data, And Low-Flow Cooling Benefits

Stereotaxis獲得歐洲CE標誌批准,用於MAGiC消融導管,增強了愛文思控股在電生理學領域的機器人技術,提供了先進的導航、改進的數據和低流量冷卻的優勢。
Benzinga ·  01/27 13:15

Stereotaxis (NYSE:STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it received European CE Mark approval for the MAGiC ablation catheter. This approval is a significant milestone for Stereotaxis and for the community of physicians pioneering robotics in electrophysiology. It is reflective of the company's commitment to advancing significant innovations that make robotics increasingly impactful across interventional medicine.

Stereotaxis(紐交所:STXS)是一家在微創內血管幹預手術機器人領域的先驅和全球領導者,今天宣佈獲得歐洲CE標誌的MAGiC消融導管的批准。該批准是Stereotaxis和在電生理學領域開創機器人技術的醫生社區的重要里程碑。這反映了公司致力於推動重大創新,使機器人在介入醫學中越來越具影響力的承諾。

Stereotaxis' MAGiC catheter is a robotically-navigated magnetic ablation catheter designed to perform cardiac ablation procedures that treat heart arrhythmia. The MAGiC catheter was developed based on insights collected over the course of nearly 20 years and 150,000 robotic ablation procedures performed using predecessor catheters. The MAGiC catheter is designed to enhance treatment precision and control during cardiac ablation, while maintaining the intrinsic safety advantage of a soft flexible catheter. It builds upon existing benefits of robotic cardiac ablation with design enhancements that include:

Stereotaxis的MAGiC導管是一種機器人導航的磁性消融導管,旨在進行治療心律失常的心臟消融手術。MAGiC導管的開發基於近20年內通過前代導管進行的150,000例機器人消融手術中收集的見解。MAGiC導管旨在提高心臟消融過程中的治療精度和控制,同時保持軟性柔性導管固有的安全優勢。它在現有的機器人心臟消融益處基礎上,進行了包括以下在內的設計改進:

  • Optimized Navigation, Force & Stability – The unique placement of magnets and design of the distal section of the catheter supports intuitive navigation, consistent contact forces, and enhanced stability.
  • Improved Data & Information – MAGiC is available with iConnect and the eContact module, offering catheter tissue contact information as well as clear electrogram and responsive temperature data to support physician decision making.
  • Efficient Low-Flow Uniform Cooling – Cooling of the tip is accomplished with low-flow irrigation that substantially reduces overall fluid load on patients while protecting against char and coagulation.
  • 優化導航、力和穩定性 – 導管遠端獨特的磁鐵放置和設計支持直觀導航、一致的接觸力和增強的穩定性。
  • 改進的數據和信息 – MAGiC與iConnect和eContact模塊一起提供,提供導管組織接觸信息以及清晰的心電圖和響應性溫度數據,以支持醫生決策。
  • 高效的低流量均勻冷卻 – 導管尖端的冷卻是通過低流量灌注實現的,這大大減輕了患者的總體液體負擔,同時保護導管免受炭化和凝固。

The MAGiC catheter has been approved in Europe with a broad label that includes the delivery of "local lesions in cardiac tissue for the treatment of cardiac arrhythmias." Obtaining the CE Mark follows years of effort and substantial investments in catheter development, testing, manufacturing, and preclinical and clinical research. Clinical experience with MAGiC in an ongoing clinical study in Europe supports expectations for broad adoption of MAGiC across robotic users.

MAGiC導管已在歐洲獲得廣泛標籤的批准,包括對「心臟組織進行局部病竈治療心律失常」。獲得CE標誌是經過多年的努力和對導管開發、測試、製造以及臨牀前和臨牀研究的重大投資。對MAGiC在歐洲正在進行的臨牀研究的臨牀經驗支持對MAGiC在機器人用戶中廣泛採用的預期。

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
評論 評論 · 瀏覽 323

熱點推薦

搶先評論

聲明

本頁的譯文內容由軟件翻譯。富途將竭力但卻不能保證翻譯內容之準確和可靠,亦不會承擔因任何不準確或遺漏而引起的任何損失或損害。