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US FDA approves Levita's magnetic surgical system

San Mateo, CaliforniaFriday, August 19, 2016, 14:00 Hrs  [IST]

Levita Magnetics, a medical technology company, released a first-of-its-kind magnetic surgical system. The platform, which recently received CE Mark and FDA clearance, represents one of the key surgical advancements in the last decade. 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 1,000,000 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 Levita Magnetic Surgical System, surgeons can now 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.

“We are proud to be the pioneers of magnetic surgery,” said Dr. Alberto Rodriguez-Navarro, surgeon, founder, and chief executive officer of Levita Magnetics. “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.”

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

The Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2.

 
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