Stereotaxis submits catheter pair for FDA clearance

Stereotaxis Inc. yesterday stated it has submitted its EMAGIN 5F catheter and its MAGiC catheter to the U.S. Meals and Drug Administration for clearance.

EMAGIN 5F, brief for Endovascular Magnetic Intervention, is a 5-French diameter that navigates tortuous venous and arterial vasculature. Stereotaxis designed it to allow environment friendly and protected navigation to entry difficult-to-reach vascular anatomy.

The firm stated EMAGIN 5F expands the established advantages of its Robotic Magnetic Navigation into a number of new medical functions, together with minimally invasive for stroke, most cancers, and heart problems.

“Robotic Magnetic Navigation gives vital promise to deal with medical challenges we face within the neuro-interventional discipline by enabling protected and speedy navigation by way of tortuous vasculature,” said Timo Krings, chair of the division of neuro-interventional radiology at Beth Israel Lahey Well being in Boston.

“I’m excited by the chance to assist pioneer this know-how, consider and exhibit its medical worth, and discover fully new functions that will develop into potential,” he stated. “Our discipline is uniquely poised to profit from robotics, and we stay up for advancing the know-how and medical science over the approaching years.”

Along with the FDA 510(okay) submission, Stereotaxis expects to submit the catheter for CE mark clearance in Europe this month. It expects to launch EMAGIN 5F within the second half of 2025 following regulatory clearances.

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Extra concerning the MAGiC Sweep catheter

The MAGiC Sweep catheter is a high-density EP mapping catheter the corporate designed to be used with Stereotaxis’ Robotic Magnetic Navigation techniques.

“The event of the first-ever robotically navigated high-density mapping catheter is a significant milestone for the EP discipline,” stated Dr. Roderick Tung, chief of cardiology and director of cardiovascular medical analysis on the College of Arizona Faculty of Medication. “Mapping with multi-electrode catheters has taught us a lot in each mechanism and remedy for each atrial and ventricular arrhythmias.”

“Remaining restricted to solely point-by-point mapping has held again the adoption of robotic navigation, as we’ve develop into accustomed to seeing human arrhythmias in exquisitely excessive decision,” he added. “We stay up for the optimistic influence we count on MAGiC Sweep to have on our sufferers and new prospects within the discipline.”

The St. Louis, Mo.-based firm stated it expects to submit MAGiC Sweep for CE mark clearance in Europe later in March. It expects to provoke a broad business launch within the second half of 2025 following regulatory clearances.

Sterotaxis begins 2025 with first GenesisX order

Stereotaxis stated GenesisX is its most accessible robotic system to this point. | Supply: Stereotaxis

In January, Stereotaxis secured the primary order for its latest-generation robotic system, GenesisX. The surgical robotic developer stated the system is geared towards minimally invasive endovascular intervention.

Steroeotaxis stated its GenesisX builds on the advantages of robotic magnetic navigation (RMN) whereas making the know-how extra accessible for healthcare suppliers, in accordance with Stereotaxis. The system does this with two enhancements. First, it makes use of smaller magnets, stated the corporate.

Second, the system incorporates magnetic shielding into its construction rather than the shielding in any other case put in within the partitions of the working room.

Stereotaxis stated that different objectives this yr embrace demonstrating real-world use of GenesisX and enhancing the compatibility of GenesisX with varied X-rays. The corporate additionally stated it hopes to arrange its provide chain, manufacturing, set up, and business processes for a full launch.

Edtior’s notice: This text was syndicated from The Robotic Report sibling website MassDevice.