Stereotaxis Inc. has taken a significant step in expanding its portfolio by submitting two advanced cardiac catheters, EMAGIN 5F and MAGiC, to the U.S. Food and Drug Administration (FDA) for approval. These submissions mark the company’s ongoing commitment to enhancing minimally invasive cardiac procedures through robotic technology. The EMAGIN 5F catheter is designed to navigate complex vascular pathways, while the MAGiC catheter offers high-density mapping capabilities. Both products are expected to reach the European market shortly after their FDA reviews.
Previous reports have highlighted Stereotaxis’ focus on robotic navigation systems. The latest submissions build on this foundation, aiming to provide more versatile solutions for healthcare providers. Compared to earlier products, these new catheters offer improved functionality and broader clinical applications, underscoring the company’s dedication to innovation in medical technology.
What are the new catheters submitted for FDA clearance?
The EMAGIN 5F catheter, short for Endovascular Magnetic Intervention, features a 5-French diameter tailored for navigating intricate venous and arterial structures. This design facilitates safer and more efficient access to challenging vascular regions. Additionally, the MAGiC Sweep catheter, a high-density EP mapping tool, is intended for use with Stereotaxis’ Robotic Magnetic Navigation systems, enhancing the precision of cardiac ablation procedures.
How will the EMAGIN 5F enhance clinical applications?
EMAGIN 5F extends the benefits of Robotic Magnetic Navigation to new clinical areas, including minimally invasive treatments for stroke, cancer, and cardiovascular diseases. Its ability to maneuver through difficult-to-reach vascular anatomy opens up possibilities for more effective interventions.
“Robotic Magnetic Navigation offers significant promise to address clinical challenges we face in the neuro-interventional field by enabling safe and rapid navigation through tortuous vasculature,”
stated Timo Krings from Beth Israel Lahey Health.
What innovations does the GenesisX system offer?
The GenesisX system represents Stereotaxis’ most accessible robotic platform to date, aimed at facilitating minimally invasive endovascular procedures. It incorporates smaller magnets and magnetic shielding within its structure, reducing the need for extensive operating room modifications. This design enhances compatibility with various X-ray systems and aims to streamline both the installation and commercial deployment processes.
Advancements like the EMAGIN 5F and MAGiC catheters, alongside the GenesisX system, signify Stereotaxis’ efforts to make robotic-assisted cardiac interventions more effective and widely accessible. By focusing on both technological improvements and practical deployment aspects, the company seeks to address the evolving needs of healthcare providers. These developments are anticipated to improve patient outcomes and expand the range of treatable conditions through minimally invasive methods.
