Levita Magnetics launched its first-of-its-kind magnetic surgery system for less invasive gallbladder removal surgery. The device recently received de novo clearance from the FDA.
The Levita Magnetic Surgical System uses magnetic retraction to grasp and maneuver the gallbladder in laparoscopic cholecystectomy, or gallbladder removal, procedures. It requires fewer incisions, or ports, than traditional surgery as it eliminates the need for invasive tools to position the gallbladder for removal.
The device comprises a magnetic grasper device with a detachable tip and a magnetic controller. The grasper enters the abdominal cavity via an incision. Once the magnetic tip reaches the gallbladder, the surgeon will deploy it, attaching it to the organ and removing the grasper. The surgeon will then use the magnetic controller to maneuver the organ from outside the patient’s abdomen and then insert a tool to remove it. Once the gallbladder is detached, the grasper is re-inserted to retrieve the magnetic tip and gallbladder.
The company hopes to make an impact on the more than 1 million cholecystectomies performed in the U.S. each year. It is the most frequently performed surgery in the U.S. and the world, said CEO Alberto Rodriguez-Navarro in an interview.
While the device was initially indicated for cholecystectomy, Rodriguez-Navarro sees gallbladder surgery as a stepping stone toward other procedures, including other abdominal surgery, general surgery and gynecological and urological procedures.
Privately-held Levita is backed by Chilean VC Aurus Capital.
- here's the statement