Levita Magnetics, a California-based company that specializes in laparoscopic systems, has recently announced that its Levita Robotic Platform, a surgical robot that is still in development, has been used to perform surgery on a patient for the first time in a hospital in Chile. The robot uses similar magnetic technology as in the company’s handheld Levita Magnetic Surgical System.
The technology developed by Levita involves using magnets that are applied externally to control and manipulate devices, such as graspers, that are inserted into the body during laparoscopic surgery. The technique has the advantage of not needing a fixed pivot point to achieve dexterous movements within the body, and the company reports that surgery performed in this way requires fewer incisions and results in reduced patient morbidity.
The new robotic platform combines this magnetic technology with a robotic system for added convenience and functionality, with the aim of creating a single-operator platform. Levita reports that the new system reduces the number of assistive personnel required by a surgeon during a procedure.
See a video below showing an animation of the handheld system in action during a prostate removal procedure:
Medgadget had the opportunity to speak with Dr. Alberto Rodriguez-Navarro, founder and CEO of Levita Magnetics, about the technology.
Conn Hastings, Medgadget: Please give us a quick overview of laparoscopic and minimally invasive surgery, and the benefits it provides for patients and surgeons.
Alberto Rodriguez-Navarro, Levita Magnetics: Laparoscopic surgery is a minimally invasive procedure performed by surgeons to treat patients with abdominal conditions and diseases indicated for surgery. The technique employs a camera, known as a laparoscope, that enables the surgeon to have a view inside the abdominal cavity and to use multiple incisions in the abdominal wall to introduce the surgical instruments needed to complete the surgery. It’s a common alternative to open surgery, which results in more severe pain, longer recovery and large scars. Laparoscopic procedures provide a less invasive procedure for patients.
Medgadget: What is the Levita Magnetic Surgical System, and how does it work?
Alberto Rodriguez-Navarro: The Levita Magnetic Surgical System, our first commercial product, is a first-of-its-kind system designed to further minimize the footprint of laparoscopic surgery. Our magnetic technology enables laparoscopic procedures with even fewer incisions, with proven patient benefits that include less pain, faster recovery and less scarring. It is the first FDA-cleared magnetic surgical system designed to magnetically grasp and retract the target tissue in laparoscopic cholecystectomy, bariatric, prostatectomy and colorectal surgical procedures.
The magnetic system facilitates improved access and visualization internally at the surgical site, and enables a reduced number of incisions and trocars during laparoscopic procedures. The system, which consists of a handheld external magnet placed on the skin that controls a shaftless detachable grasper, enables instruments to move without the constraints of a fixed-position pivot point through an incision in the abdomen. The system has been clinically proven to reduce pain and the number of scars, and quicken recovery.
Medgadget: What advantages does the system provide over other laparoscopic surgical technology?
Alberto Rodriguez-Navarro: Laparoscopic surgery has been conducted for approximately 40 years without major changes. In recent years, laparoscopic surgeons have searched for ways to reduce the number of incisions, or ports, to further improve the potential patient benefits verses open surgery.
However, port reduction can be associated with technical challenges during surgery. As a practicing surgeon myself, I’ve seen this first hand over the last decade. In conventional laparoscopic procedures, shafted surgical instruments are introduced by fixed-position trocars inserted through incisions in the abdomen. Shafted instruments can impair surgeon visualization by cluttering the operative field, causing instrument collisions and restricting movement. The use of trocars can risk injury to the major bowel and vessels and cause incisional pain, bleeding, scarring, hernias and infections. Magnetic retraction is a very elegant solution to this problem, as it enables the traction, or movement, of intra-abdominal organs without the restriction of a fixed incision. It is a very versatile technology that improves the capability of movement, control and visualization.
Medgadget: Please talk us through the latest technology developed by Levita Magnetics, the Levita Robotic Platform, and the features it offers.
Alberto Rodriguez-Navarro: The Levita Robotic Platform is taking our proprietary magnetic technology to the next level. It was designed with patients, surgeons and hospitals in mind. We consider it a triple impact technology, as it provides benefits to the patients, surgeons and hospitals. For patients, it includes delivering the established clinical benefits of the Levita Magnetic Surgical System, including less pain, faster recovery and less scarring; for surgeons, improving visualization and maintaining control of all laparoscopic instruments; and for hospitals, increasing overall hospital efficiency with fewer assistants required to conduct the procedures. We specifically designed the platform for high volume abdominal surgeries, such as bariatric surgeries and gallbladder removals. Our robotic platform is also designed to be compatible with ambulatory surgical centers as our technology helps enable same-day discharge from the hospital.
The design of the robot itself adapts the handheld model of the Levita Magnetic Surgical System to a fully robotic and single-operator platform. Unlike the traditional robotic model, where the surgeon is displaced from the patient at a console to control the robot, the Levita robot employs a different operating model where the surgeon is next to the patient through the duration of the procedure. It is designed to allow the surgeon to remain entirely hands-on at the procedure site during surgery with less surgical assistance required in the operating room.
We believe the combination of all these benefits will increase the volume of high-quality, efficiently performed procedures that finally will improve patient access and reduce the waiting times for the surgeries they need.
Medgadget: The Robotic Platform recently treated its first patient. Please give us an overview of the trial and how it went.
Alberto Rodriguez-Navarro: Our first clinical study of our Levita Robotic Platform is currently being conducted in Chile, my native country, and is designed to further optimize the system based on surgeon feedback. The first surgery using the platform was for a patient who needed their gallbladder removed. As a part of the study, this patient received a reduced-incision laparoscopic cholecystectomy performed by Dr. Ignacio Robles, a minimally invasive surgeon at Clínica INDISA in Santiago. The patient was able to return home in less than 24 hours without pain and had no complications reported at 30 days of follow up. Since then, two more patients with acute conditions were entered in the study and had their surgeries completed the day they were enrolled. We believe the Levita Robotic Platform was well-suited to the currently constrained health care environment, with hospital infrastructure and health care providers under significant stress due to ongoing COVID-19 challenges. While the pandemic conditions are unfortunate, it has had the unplanned effect of highlighting the potential for the Levita Robotic Platform to increase accessibility and improve the quality of surgery for those in need.
Medgadget: What are the next steps for the new system? When do you anticipate that it might be available, pending positive results?
Alberto Rodriguez-Navarro: Following the completion of the study, we will submit the Levita Robotic Platform to the FDA for clearance by the end of 2021. We are anticipating launching commercially in the first half of 2022, and we already are in discussions with highly regarded centers in the U.S. that will be the first to receive a Levita Robotic Platform. After this limited U.S. launch, our objective is to reach hospitals nationally across the U.S. before launching internationally to bring this technology to as many patients as possible. Our goal is to change the way surgery is performed at a global scale.
Flashbacks: Levita Magnetic System Eliminates an Incision for Some Laparoscopic Surgeries; Levita Magnetic Surgical System Cleared by FDA for Prostatectomies; Magnetically Operated Surgical Tool Cleared for Weight Loss Operations