August 13, 2024 - Stereoaxis, a leader in minimally invasive intravascular interventional magnetic navigation robotics, has announced the successful acquisition of the CE Mark for its new generation vascular interventional robot, Genesis X, and the submission of a registration application to the U.S. FDA. The company expects FDA approval for the compatible catheters in the coming months and plans to demonstrate the real-world application of the surgical robot system. This initiative is aimed at enhancing its compatibility with various X-ray technologies in preparation for a comprehensive rollout and mass promotion of Genesis X in 2025.
Genesis X
Building on the foundation of Stereoaxis’s previous generation robot, the Genesis RMN, Genesis X incorporates the advantages of the Genesis RMN System while simplifying the deployment process for doctors and hospitals:
Product Advantages
· Genesis X features smaller magnets and integrates magnetic shielding within its structure, eliminating the need for additional magnetic shielding in operating room walls.
· The robot is not anchored to the operating room floor and operates using standard 120/230V power outlets.
· Each robot is connected by a single optical fiber to a system cabinet that is 80% smaller than that of the Genesis RMN, allowing it to fit under an operating room table.
Previously, facilities that wanted to use the Genesis RMN System often had to undergo significant structural changes, including the installation of heavy magnetic shielding on walls, floor reinforcement, and extensive wiring between the operating room and a dedicated equipment room. This process required extensive planning and coordination among site planners, architects, and contractors.
Overall, Genesis X offers a more compact and lightweight design than its predecessors while maintaining the speed, responsiveness, and efficient workflow advantages of the Genesis series.
Genesis RMN
In March 2020, the FDA approved the upgraded magnetic navigation surgical robot, Genesis RMN System.
This system utilizes two magnets near the catheter bed to control a uniform magnetic field. During procedures, doctors adjust the magnetic field around the patient using a computer interface, allowing for precise manipulation of a catheter embedded with a magnetic module at its tip.
· Speed: The Genesis RMN employs smaller magnets that rotate around their center of mass, offering rapid and precise responses to doctor’s controls. It is 70%-80% faster in navigation procedures than Stereotaxis’s Niobe.
· Compact Size: The Genesis RMN is 40% smaller than Stereotaxis Niobe, providing more space and improving the work environment. Its magnetic navigation system offers unparalleled catheter precision and range, enabling stable contact within a beating heart, thereby enhancing safety and improving the surgical experience. Moreover, Genesis RMN is easier to install and maintain, features more automation, and supports remote surgeries.
Company Updates
· In 2024, Stereotaxis filed for approval of its Magnetic Interventional Ablation Catheter (MAGiC), designed for minimally invasive cardiac ablation surgeries, with European and U.S. authorities. The majority of formal testing has been successfully completed, with CE approval anticipated by mid-year and FDA approval expected later in the year.
· On May 14, 2024, Stereotaxis announced its acquisition of electrophysiology catheter manufacturer Access Point Technology (APT), entering the electrophysiology ablation consumables market.
· On May 24, 2024, Stereotaxis achieved re-certification under the new European Union Medical Device Regulation (MDR) framework, covering all devices currently offered by the company in Europe.
About Stereotaxis
Founded in 1990, Stereotaxis is a global pioneer in innovative robotic technologies for electrophysiology. The company is dedicated to providing robotic systems and solutions for interventional catheter rooms, enhancing surgical precision, efficiency, and safety. Stereotaxis introduced the world's first magnetic navigation electrophysiology robot, Niobe, in 2003. Its upgraded Genesis RMN system received FDA approval in 2020. The core components of Stereotaxis’s electrophysiology robotic systems are also registered and approved in China, Japan, the European Union, Canada, and other regions.
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