Levita Magnetics Announces FDA Clearance of Expanded Indication for Magnetic Surgical System for Use in Bariatric Procedures

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October 22, 2018

Levita Magnetics, a company dedicated to improving the outcomes of surgical procedures through Magnetic Surgery®, today announced that the U.S. Food and Drug Administration (FDA) has granted the company an expanded indication to market the company’s first-of-its-kind Levita® Magnetic Surgical System for use in bariatric procedures. Initially indicated for use in gallbladder removal procedures, the shaftless Magnetic Surgical System reduces the number of incisions necessary for the indicated procedures.

Levita Magnetics highlights the Levita System is designed to facilitate access and visualization of the surgical site while minimizing invasiveness. In conventional laparoscopic procedures, shafted surgical instruments are introduced by fixed-position trocars inserted through incisions in the abdomen. The use of trocars is associated with risks relating to major bowel and vessel injury, incisional pain, bleeding, scarring, hernias, and infection. In addition, shafted instruments can impair surgeon visualization by cluttering the operative field, cause instrument collisions, and restrict movement as a result of their fixed pivot point. The shaftless Levita System reduces the number of incisions and trocars necessary, while also providing surgeons the ability to move instruments without the constraints of a fixed-position pivot point.

“Magnetic Surgery with the Levita System will allow us to offer a less invasive alternative to our bariatric patients. Bariatric surgery patients are interested in new options that minimize incisions and result in better cosmetic outcomes, and the Levita System has been effective in delivering these results in our preliminary experience to date,” said Dana Portenier, M.D., Chief of the Metabolic and Weight Loss Surgery division at Duke University Health System in Durham, North Carolina. “I have used the Levita System since its initial FDA clearance, and believe it is an important new option for patients electing to undergo bariatric surgery.”

According to the Centers for Disease Control and Prevention (CDC), nearly 40 percent of U.S. adults (93 million Americans) have a body mass index classifying them as obese.1 Long-term evidence from studies of bariatric surgery outcomes has demonstrated a significant benefit for weight loss as well as diabetes recovery, a lower risk of cardiovascular disease, and other metabolic and musculoskeletal benefits.2 There has been a 44 percent increase in bariatric procedures in the United States since 2011.3

“This new indication is another exciting milestone for Levita and a significant step toward fulfilling our vision to enhance patient outcomes by minimizing the footprint of surgical procedures across multiple indications and broad patient populations,” said surgeon Alberto Rodriguez-Navarro, CEO and founder, Levita Magnetics. “We are pleased that our technology allows surgeons to offer a less-invasive alternative to patients considering bariatric procedures.”

To date, patients have undergone Magnetic Surgery at leading clinical centers including the Cleveland Clinic, UT Southwestern Medical Center, Stanford University and Duke University, among others.

The Levita Magnetic Surgical System enables reduced-port laparoscopic surgical procedures designed to minimize the footprint of surgery. The system, which consists of an 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, and facilitates access and visualization of the surgical site.

In the United States, the Levita Magnetic Surgical System is indicated to grasp and retract the body and the fundus of the gall bladder in laparoscopic cholecystectomy procedures and the liver in bariatric procedures to facilitate access and visualization of the surgical site in patients with a BMI range of 20-60 kg/m2.


References

1 https://www.cdc.gov/nchs/data/databriefs/db288.pdf

2 Panagiotou OA, Markozannes G, Adam GP, et al. Comparative Effectiveness and Safety of Bariatric Procedures in Medicare-Eligible PatientsA Systematic Review. JAMA Surg. Published online September 05, 2018. doi:10.1001/jamasurg.2018.3326

3 https://asmbs.org/resources/estimate-of-bariatric-surgery-numbers

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