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Product approval

Levita gains FDA approval of magnetic system for bariatrics

Shaftless Levita System reduces the number of incisions and trocars necessary, while also providing surgeons the ability to move instruments without the constraints of a fixed-position pivot point

Levita Magnetics has gained FDA approval for its Levita Magnetic Surgical System for use in bariatric procedures. Initially indicated for use in gallbladder removal procedures, the shaftless Magnetic Surgical System reduces the number of incisions necessary for the indicated procedures, the company stated. The system, which consists of an external magnet placed on the skin that controls a shaftless detachable grasper, enables instruments to move without the constraints of a fixed-position pivot point, and facilitates access and visualisation of the surgical site.

“Magnetic Surgery with the Levita System will allow us to offer a less invasive alternative to our bariatric patients. Bariatric surgery patients are interested in new options that minimize incisions and result in better cosmetic outcomes, and the Levita System has been effective in delivering these results in our preliminary experience to date,” said Dr Dana Portenier, Chief of the Metabolic and Weight Loss Surgery division at Duke University Health System in Durham, North Carolina. “I have used the Levita System since its initial FDA clearance, and believe it is an important new option for patients electing to undergo bariatric surgery.”

In the US, the Levita Magnetic Surgical System is indicated to grasp and retract the body and the fundus of the gall bladder in laparoscopic cholecystectomy procedures and the liver in bariatric procedures to facilitate access and visualisation of the surgical site in patients. The shaftless Levita System reduces the number of incisions and trocars necessary, while also providing surgeons the ability to move instruments without the constraints of a fixed-position pivot point.

“This new indication is another exciting milestone for Levita and a significant step toward fulfilling our vision to enhance patient outcomes by minimizing the footprint of surgical procedures across multiple indications and broad patient populations,” said surgeon Alberto Rodriguez-Navarro, CEO and founder, Levita Magnetics. “We are pleased that our technology allows surgeons to offer a less-invasive alternative to patients considering bariatric procedures.”

To date, patients have undergone Magnetic Surgery at leading clinical centres including the Cleveland Clinic, UT Southwestern Medical Center, Stanford University and Duke University, among others.

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