Medical device developer Levita Magnetics said it won FDA de novo clearance for its magnetic surgical system with indications for gallbladder removal surgery, and launched the system in the U.S.
The system is designed to retract and maneuver the gallbladder using magnetic fields, which the San Mateo, Calif.-based company said “reduces the number of incisions” necessary for the procedure and prevents damage to the abdominal wall.
“The other advantage that we have seen is you can really manipulate the external magnet over the surface of the patient. You can generate angles of traction like exposure that is much more flexible than the conventional instruments that you are limited by the entry point. It is a different and more versatile technology. We are just in the beginnings of seeing all of the capabilities that brings to surgery,” CEO Dr. Alberto Rodriguez-Navarro told MassDevice.com
The company said that the FDA created a new category to accommodate the unique magnetic surgery platform, and said the platform also recently won CE Mark approval in the European Union.
“We are the first movers in magnetic surgery for urosurgery and abdominal procedures. We see that it has a great potential and that is our objective as a mission. We have a pipeline for others’ ideas and products and we want to keep developing,” Rodriguez-Navarro said.
Rodriguez-Navarro said the company is developing future devices using the same concept, though they are currently at a confidential stage of development.
“This is our initial entry to the market. We have to figure out where is the biggest need, where we can bring more value, and where to focus our efforts on those next topics that we will find,” Rodriguez-Navarro said.
“We are at the beginning of an exciting advance in surgery and I look forward to using magnetic surgery to help my patients,” Dr. Matthew Kroh of the Cleveland Clinic, the 1st to use the system, said in a press release.
The post UPDATE: Levita Magnetics wins de novo FDA clearance for gallbladder surgery device appeared first on MassDevice.
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