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Saturday, May 11, 2024

FDA Clears New Surgical Platform Combining Robotics & Magnetics


This week, a brand new robotic platform designed to extend surgical effectivity gained clearance from the FDA. The company cleared Levita Magnetics’ platform, which mixes the corporate’s proprietary magnetic surgical expertise with robotic help. 

In 2016, Levita commercially launched its magnetic surgical procedure system, which is supposed to make belly surgical procedures much less invasive. The commonest belly surgical procedure, gallbladder removing, requires surgeons to make at the least 4 incisions.

Levita’s magnetic surgical procedure system reduces this to only one incision by inserting magnets right into a affected person’s physique by means of their stomach button. The surgeon can then maneuver these with magnetic arms outdoors the affected person’s physique to retract massive tissues or an organ, such because the gallbladder, liver, prostate or colon. Surgeons at well being programs throughout the nation — together with Cleveland Clinic, Mayo Clinic and Duke College Well being System — use the magnetic surgical procedure platform to carry out belly surgical procedures.

Levita’s freshly cleared system is comparable, however improved, mentioned the corporate’s CEO, Alberto Rodriguez-Navarro, in a current interview. On this system, referred to as the MARS system, robotic assistants are shifting the magnets contained in the affected person’s physique.

Levita’s new platform will ship all the identical affected person advantages as its unique magnetic surgical procedure system — comparable to diminished incisions, much less ache, fewer scars and speedier restoration — whereas additionally giving surgeons higher management of their devices. The brand new system additionally permits surgeons to carry out procedures utterly by themselves.

Within the late 90s, Intuitive Surgical burst onto the scene as disruptive pioneer within the robotic surgical procedure house. However robotics have been part of the surgical discipline for some time now, and this house is at present missing innovation, Rodriguez-Navarro declared. His firm’s robotic surgical system will stand out from others available on the market as a result of it combines each robotics and magnetics, he famous.

With robotic help, surgeons can have full management over their devices, eliminating the necessity for a number of physicians within the working room. This is a crucial good thing about Levita’s new system, given the workforce scarcity and suppliers’ want to extend effectivity, Rodriguez-Navarro identified. Outpatient hospital clinics and ambulatory surgical procedure facilities (ASCs) can actually profit from elevated effectivity and optimized deployment of working room personnel, he declared. 

“It’s a big development for main belly surgical procedures to be carried out in an outpatient or ambulatory surgical settings. Our resolution is concentrated on that surroundings — the place you want a small footprint, and you might want to velocity up the workflow to make the surgeon extra environment friendly. Additionally, one of many massive points on this surroundings is that you might want to management sufferers’ ache with a purpose to ship them house on the identical day. Our system reduces incisions and reduces ache, so it’s very well-fit for the idea of sending the affected person house the identical day,” Rodriguez-Navarro defined.

Levita’s deal with the distinctive wants of belly surgeons, in addition to its use of magnetic surgical procedure strategies helps it stand out from different corporations promoting robotic surgical procedure platforms, comparable to Intuitive Surgical and Moon Surgical, he added.

Picture: Levita Magnetics

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