FDA Grants De Novo Clearance To Levita's Magnetic Gallbladder Surgery Device
By Jof Enriquez,
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Levita Magnetics has launched a first-of-its-kind magnetic surgical system for gallbladder removal shortly after receiving de novo clearance from the U.S. Food and Drug Administration (FDA). The device is said to be so unique that FDA had to create a new category to accommodate this new technology.
The system utilizes magnetic fields to remove the gallbladder. After insertion of a magnetic grasper device, a deployable tip grasps the gallbladder and detaches temporarily from the shaft of the grasper. Then, an external magnetic controller positioned on the abdominal wall is maneuvered to magnetically attract the end of the detachable grasper tip intra-abdominally, aligning it with the retrieval shaft to remove the gallbladder.
Typically, surgeons need to maneuver the gallbladder through a hole (port) in the abdominal wall, but the magnetic system eliminates the need for a dedicated trocar and shafted instrumentation that may clutter the operative field during a reduced port laparoscopic cholecystectomy procedure, and offers fewer complications, such as organ injuries or bleeding, and less visible scarring, says Levita.
“We are proud to be the pioneers of magnetic surgery,” says Dr. Alberto Rodriguez-Navarro, surgeon, founder, and CEO of Levita Magnetics, in prepared remarks. “Having been a minimally invasive surgeon for over 10 years, I understand the complexity my peers face when trying to gain proper access to organs. Our goal at Levita is to equip surgeons with the technology they need to make surgery easier and less invasive, while enabling improved patient outcomes.”
With the de novo clearance, Levita aims to make a sizable impact with its breakthrough device, given that more than 1,000,000 cholecystectomies are performed annually in the U.S. alone. The company says Cleveland Clinic, Stanford University, and Duke University are early partners in using what Levita calls "one of the key surgical advancements in the last decade."
Dr. Matthew Kroh, Director of Surgical Endoscopy at Cleveland Clinic and the first surgeon to use this technology in the U.S., remarked, “We are at the beginning of an exciting advance in surgery and I look forward to using magnetic surgery to help my patients.”
Levita's Magnetic Surgical System also gained recently CE Mark approval in the European Union (EU).
The medical device startup based in San Mateo, California considers its innovative magnetic surgical platform a catalyst in the continuing evolution of minimally-invasive surgery.