Author: Eugene Cho, MD
Levita Magnetics received FDA approval for the Levita Magnetic Surgical System on August 16, 2016.
This device is a magnetic surgical system. It is approved to grasp and retract the gallbladder during laparoscopic cholecystectomy procedures to facilitate visualization of the surgical site. It consists of a laparoscopic delivery system with a detachable end effector/grasper and an external magnet. The grasping component is inserted through a 10-mm trocar for delivery into the abdominal cavity, where the distal tip is used to grasp the gallbladder. Once grasping the gallbladder, the distal tip of the instrument is then detached from the shaft. It must then be manipulated into proximity of the external magnetic controller component placed on the abdominal wall. By moving the magnet on the external abdominal wall, the surgeon is able to change the degree of gallbladder retraction. The magnetic controller can be attached to standard retraction arm bracket systems. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2.
There is limited data to support its use. Results from 50 patients between January 2014 and August 2015 were reported in a single arm open label prospective proof of concept trial without adverse effects published in the January 2018 Annals of Surgery (Annals of Surgery: January 2018 – Volume 267 – Issue 1 – p 88–93).
This is a first of its kind approval, so the FDA has not determined this device to be substantially equivalent to predicate devices.
- Patients within a body mass index of 20-34 kg/m2 undergoing laparoscopic cholecystectomy
- Body mass index less than 20 or greater than 34 kg/m2