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Magnetic Surgical System Receives FDA Clearance

August 17, 2016 By Levita Magnetics

Levita Magnetics has released a new magnetic surgical system. The platform, which recently received CE Mark and FDA clearance, represents a key surgical advancement.

Initially indicated for gallbladder removal surgery, it is used to magnetically retract and maneuver the gallbladder, reducing the number of incisions. Magnetic surgery is so unique that the FDA created a new category to accommodate this technology.

With more than a million gallbladder removal surgeries, or cholecystectomies, performed each year in the United States alone, the Levita system is set to make a wide impact. Previously, surgeons would need to maneuver the gallbladder through a hole (port) in the abdominal wall.

Using the system, surgeons can maneuver and lift the gallbladder using a magnetic field without damaging the abdominal wall. This may represent fewer complications during the surgery (such as organ injuries, bleeding, or pain), a better procedure for the surgeon with less instrument crowding, and less scarring for the patient.

Major healthcare institutions including the Cleveland Clinic, Stanford University, and Duke University are working with Levita to leverage this surgical platform. Dr. Matthew Kroh, Director of Surgical Endoscopy at Cleveland Clinic and renowned surgeon innovator, was the first to use this technology in the U.S.

“We are at the beginning of an exciting advance in surgery and I look forward to using magnetic surgery to help my patients,” Dr. Kroh said.

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