Levita Magnetics announced today that it received expanded FDA 510(k) clearance for its MARS (magnetic-assisted robotic surgery) system.
The FDA granted 510(k) clearance for its Magnetic Surgical System (MSS), combined with MARS, in bariatric and hiatal hernia repair. Mountain View, California-based Levita says the expanded indication reinforces its ability to support surgeons treating patients with obesity-related conditions. It provides a less invasive solution that enables simultaneous treatment of hiatal hernias during bariatric surgery.
FDA clearance enables clinicians to use the MARS system’s Dynamic Magnetic Positioning technology. This retracts the liver and enhances visibility and access during hiatal hernia repairs. Clearance offers an innovative, less invasive option for abdominal surgery and paves the way for broader adoption of the technology, Levita said.
“This milestone reinforces our commitment to expanding access to better surgery,” said Dr. Alberto Rodriguez-Navarro, founder and CEO of Levita Magnetics. “We’re building a future where less invasive means more effective.”
Additionally, the FDA gave the green light to the company’s new 12.5 mm magnetic grasper. Levita engineered the grasper to improve visualization and control in patients with high BMI and large or difficult-to-retract livers. The device allows surgeons to grasp the liver more centrally, rather than from the edge. This improves surgical access in both hernia and bariatric procedures.
MARS introduces a new paradigm of robotic surgery, using magnetic technology to reposition organs internally. It reduces the number of incisions and enables complete control during laparoscopic procedures.
The system comes in a compact footprint designed to fit into existing operating rooms. It builds on the success of the company’s first commercial product, the Levita Magnetic Surgical System. Levita designed MARS to deliver the same patient benefits while empowering surgeons with increased control of surgical instruments.
