Levita Magnetics today announced the international launch of its MARS (magnetic-assisted robotic surgery) system with its placement at Hospital Luis Tisne in Santiago, Chile.
Dr. Julio Jimenez used the system to perform same-day-discharge cholecystectomies (gallbladder removal) and bariatric surgeries.
Jiminez previously helped Levita Magnetics with its clinical trials, said Levita Magnetics founder, CEO and President Dr. Alberto Rodriguez-Navarro.
Rodriguez-Navarro is a minimally invasive surgeon from Chile who worked in the public system for nearly 10 years before halting his clinical practice and moving to the U.S. to develop the magnetic technology.
“Returning to my home and bringing something new, something better, it’s really kind of an emotional moment,” he said from Chile in an interview with MassDevice.
Mountain View, California-based Levita designed the MARS platform for high-volume abdominal surgeries such as laparoscopic bariatric surgeries, cholecystectomies, and prostate and colorectal procedures. The MARS system was recently used for its first U.S. commercial cases at the Cleveland Clinic.
The company’s first-generation Magnetic Surgical System (MSS) won FDA de novo approval in 2015 for single-incision laparoscopic cholecystectomy (gallbladder removal). A magnetic controller placed on the skin of the patient connects with a detachable grasper inside the patient’s abdomen to hold and manipulate the gallbladder, leaving the incision site open for access and visualization.
The system’s indications expanded beyond cholecystectomies with later 510(k) clearances. The grasper can now be used to increase visualization and access by grabbing and retracting the liver in bariatric procedures; the prostate and periprostatic tissue in prostatectomies; and the colon, rectum, and pericolorectal tissue in colorectal procedures.
This year, Levita secured FDA 510(k) clearance for its updated MARS system, which added two collaborative, surgeon-controlled robotic arms. One of those arms can hold and operate the magnetic controller, which was previously operated by an assistant. The second arm holds and controls an endoscope with a camera for visualization inside the patient, leaving the surgeon’s hands free to perform procedures with laparoscopic instruments.
The MARS system also allows the surgeon to control the robotic arms with hand and foot controls, or by guiding the arms by hand.
Levita says the technology allows for better visualization, fewer operating room personnel needed for each procedure and fewer incisions, resulting in less pain, less scarring and faster recoveries. The company says it’s the only device developer with FDA clearance for magnetic technology that reduces the number of incisions for less-invasive surgery.