Gallbladder removal is a very common procedure, accounting for more than 700,000 surgeries in the United States each year, at a dramatically high cost to health care providers. Traditionally, the procedure has required numerous incisions, which cause a long and painful recovery process. Even as the need for multiple incisions, or ports, has decreased, surgeons have sought a method for better visualization during surgery.
Levita Magnetics, a San Mateo, California-based medical device company, has spent over a decade developing a magnetic surgical system to ease some of the challenges associated with common procedures, starting with gallbladder removal through a single incision. By using magnets through the abdominal wall to maneuver tools during surgery, surgeons can benefit from a better view of the operative field. Fewer incision points can lead to less post-operative pain and scarring and a shorter recovery period. The U.S. Food and Drug Administration approved the company’s system, which includes a grasper device and detachable tip, in 2016.
When it was time to begin offering the system to surgeons in the field, the company went straight to some of the nation’s foremost surgeons. Matthew Kroh, the director of surgical endoscopy at the Cleveland Clinic, was the first to use the technology. Since then, major surgery centers at Stanford and Duke Universities have also partnered with Levita.
Levita Magnetics founder and CEO Alberto Rodriguez-Navarro spoke with Smithsonian.com about his first-of-its-kind system.
How did the idea for the company come about?
I’m a surgeon and spent 10 years working in a public hospital in the poorest area in Santiago, Chile, where I’m from. One of the biggest issues with surgery is avoiding pain. In surgery, pain is related to incisions, so the more incisions, the more pain a patient will have. When we reduce the number of incisions, a patient has less pain.
My father is a mechanical engineer, and he was thinking about this problem on his own. We began playing around with magnetics. You know those fish aquariums that you can clean without changing the water? Our system is a bit like that system—it’s the same concept but applied to surgery. Instead of the glass of the tank between the two areas, it’s an abdominal wall. We developed our first prototype in Chile more than 10 years ago. We filed our first patent in Chile and used our company for developing the idea, but we were pretty relaxed about it.
How did you advance the idea from there?
I did not expect this would change my life. But an important thing to note is that the Chilean government is trying to be a hub of health care in Latin America. There is a lot of effort being directed at helping entrepreneurs develop new things. In Chile, we proved our system successful for more advanced procedures. We also got commercial approval for Europe. But we chose to focus on the U.S. first.
The Chilean government sponsored some of our research and development, as well as my entrepreneurship training at SRI International (formerly the Stanford Research Institute). The chance of developing this further in Chile was small, so I stopped clinical practice in Chile, and we moved to the Bay Area in early 2013.
We finalized our clinical product in early 2014, completed clinical trials to earn a CE Mark for consumer sales in Europe in 2015, and the FDA approved our new technology in 2015. The FDA has been very supportive and created a new classification for our technology, “Magnetic surgical instrument system.”
How does your magnetic surgery system work?
A magnetic grasper device delivers and retrieves a detachable tip that clamps onto the gallbladder that can also be repositioned. The magnetic grasper fits through a single entry point, such as the navel. Then a magnetic controller positioned outside the abdominal wall is used to maneuver the tip into the desired position. It was designed to look and be simple.
Levita Magnetics is named for how our detachable tip can sort of levitate inside the abdomen.
What are some of the most obvious benefits?
Laparoscopic surgery can require four or five multi-port incisions. Surgeons end up lacking triangulation when they move from multi-port to a reduced port model. This can lead to instrumentation clashing and poor visualization, which leads to increased difficulty in the operating room and overall increased risk in performing surgery. One port limits movement.
With our external magnet, a surgeon can let go, so that mobility is not limited. Additionally, single-port visibility is not limited once a surgeon lets go. It’s a little like driving. If you can see well, you can go fast, securely. If you have to go slowly, that costs more resources.
How has adoption been in the field?
Surgeons can be very conservative—I say as a surgeon and as someone who knows surgeons—and they often do what they know. That means adoption among surgeons can be much slower than in other fields, and our task was to develop convincing scientific evidence. The technology itself is very manageable. Surgeons at Duke University and the Cleveland Clinic and several other institutions already use our system. Once surgeons adopt it, they really stick with it.
Why start with gallbladders? What’s next for Levita Magnetics?
Gallbladder surgery is the simplest abdominal surgery and one of the most common. But we see many other opportunities to eventually expand to thorax, bariatric, colorectal, and urological and gynecological surgeries.
We’re also moving into working with robotics to give more tools to the surgeons. We want to offer a system with more than one magnet on the field to provide a complete view. This would be especially advantageous in operating rooms where there are not two surgeons present, where there might be one surgeon and one medical student or assistant. Offering a surgeon a better option is also better for patients. It reduces invasiveness, increases safety, and is also a better use of human resources.
We have 14 issued or pending patents, including three patents [U.S. Patent Numbers 8,790,245, 8,764,769 and 9,339,285] granted in the United States. We also have an article coming out in the highly prestigious medical journal Annals of Surgery this spring. This is a good sign that we’re on the right track.