FDA Extends Use of Levita Magnetics' MARS for Minimally Invasive Bariatric and Hernia Surgery

Levita Magnetics, a leader in surgical innovation, has announced that the U.S. Food and Drug Administration (FDA) has expanded the clearance for their Magnetic Surgical System (MSS) to include its use in bariatric and hiatal hernia procedures. This advanced indication will enable surgeons to treat patients suffering from obesity-related conditions more effectively, offering a less invasive approach which also permits the concurrent treatment of hiatal hernias during bariatric surgery.

The newly granted clearance permits the use of the MARS system's Dynamic Magnetic Positioning™ technology for liver retraction, improving visibility and access during hiatal hernia repairs. This advancement presents a novel, less invasive option for abdominal surgeries and is expected to facilitate broader adoption of the technology across hospitals and surgical centers nationwide. The approval also involves the introduction of Levita's new 12.5mm magnetic grasper, designed to enhance visualization and control, especially for patients with high BMI and larger or more challenging livers. This grasper allows surgeons to centrally grasp the liver, providing improved surgical access in both hernia and bariatric operations.

Dr. Chad Carlton, a surgeon based in Dallas and an experienced user of the MARS system, commented on the significance of this clearance. He highlighted that the improved grasper and magnetic liver retraction enable more complex surgeries with better visibility and fewer incisions. This new technique represents a smarter, less invasive solution for patients, particularly those with high BMI and complex anatomy, resulting in reduced pain and recovery time.

Unlike traditional robotic systems that often depend on rigid instruments and multiple incisions, the MARS platform introduces a fresh approach by employing proprietary magnetic technology to internally reposition organs. This not only reduces the number of incisions required but also minimizes tissue trauma, enhancing patient recovery while maintaining surgical precision and control.

Dr. Alberto Rodriguez-Navarro, founder and CEO of Levita Magnetics, emphasized the company's commitment to making surgery more accessible and effective through less invasive means. The updated clearance significantly strengthens Levita's ability to support the high-demand patient population that requires hiatal hernia repair alongside bariatric surgery, enhancing access and visualization with magnetic retraction and an improved set of tools.

With the expanded indication and the introduction of the new 12.5mm grasper, Levita is broadening its market reach and bolstering its commercial offerings to surgical teams dealing with complex abdominal cases. Levita's continuous innovation is pioneering new possibilities in surgical care, enabling groundbreaking bariatric procedures and surgeries aimed at enhancing life quality. The MARS platform is redefining surgical capabilities, supported by a growing number of clinical use cases and media coverage highlighting improved patient outcomes.

Levita Magnetics is also extending its clinical presence both nationally and internationally, and the company anticipates the installation of systems in several top-tier institutions in the near future. The MARS platform, which is FDA-approved for gallbladder, bariatric, prostate, colorectal, and now hiatal hernia surgeries, is a testament to Levita's role in revolutionizing the landscape of magnetically assisted surgeries.