SAN MATEO, Calif.--(BUSINESS WIRE)--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 first-of-its-kind Levita® Magnetic Surgical System for use in prostatectomy procedures. Initially indicated for use in laparoscopic cholecystectomy (gallbladder removal) and bariatric surgical procedures, the shaftless Magnetic Surgical System reduces the number of incisions necessary for minimally invasive procedures.
Prostatectomy is a surgery performed to treat prostate cancer, which is the second most common cancer among men. Each year, more than 174,000 new cases of prostate cancer are diagnosed, and 1 in 9 men will be diagnosed with prostate cancer in his lifetime.1 A prostatectomy is commonly recommended if prostate cancer has not spread outside the prostate gland. In this procedure, a surgeon removes the prostate and some of the tissue around it.2
“With the Levita Magnetic Surgical System, I am able to offer a less invasive prostatectomy to my patients, combining Magnetic Surgery with robotic-assisted surgery,” said Jeffrey Cadeddu, M.D., professor of urology and radiology at University of Texas Southwestern Medical Center. “The Levita System is a magnetically controlled surgical tool that facilitates access to the surgical site and declutters the surgical field, while reducing the number of incisions required to perform this delicate surgery. Magnetic Surgery facilitates a seamless, reduced-port prostatectomy.”
Matthew Gettman, M.D., professor of urology at Mayo Clinic, will present results from the first clinical evaluation of Magnetic Surgery for prostatectomy at the American Urological Association’s Annual Meeting in Chicago, on Sunday, May 5 at 4:38 p.m. CDT, during the Plenary Session: Late-Breaking Abstracts.
The Levita System consists of an external magnet placed on the skin that controls a shaftless detachable grasper that enables surgeons to move the grasper without the constraints of a fixed-position pivot point. In conventional laparoscopic procedures, shafted surgical instruments are introduced by fixed-position trocars inserted through incisions in the abdomen. These trocars are associated with major bowel and vessel injury, incisional pain, bleeding, scarring, hernias and infection. Using shafted instruments can also impede the surgeon’s view into the surgical field, cause instrument collisions and restrict movement. The Levita System was designed to address these challenges by reducing the number of incisions and trocars used and facilitating access and visibility to the surgical site, ultimately enabling safe procedures with better cosmetic outcomes.
“This newest indication marks significant progress for our technology that allows surgeons to offer prostatectomy with a new, less invasive alternative to patients,” said Alberto Rodriguez-Navarro, M.D., founder, president and CEO of Levita Magnetics. “Adding prostatectomy is another exciting milestone toward fulfilling our vision to minimize the footprint of surgery across multiple indications and broad patient populations with Magnetic Surgery, the next step in the evolution of minimally invasive surgery. We are looking forward to showcasing Magnetic Surgery at the AUA Meeting later this week.”
Major healthcare institutions have been involved in the early use of the Levita Magnetic Surgical System, including Cleveland Clinic, Mayo Clinic, Stanford University, Duke University and UT Southwestern Medical Center.
About the Levita® Magnetic Surgical System
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 gallbladder in laparoscopic cholecystectomy procedures, the liver in bariatric procedures and the prostate and periprostatic tissue in prostatectomy procedures to facilitate access and visualization of the surgical site in patients with a BMI range of 20-60 kg/m2.
About Levita® Magnetics
Headquartered in Silicon Valley, Levita Magnetics developed the first and only Magnetic Surgery® platform, the Levita Magnetic Surgical System. Founded by innovator and surgeon Dr. Alberto Rodriguez-Navarro, this proprietary technology is designed to evolve minimally invasive surgery with the goal of minimizing the footprint of surgery and improving patient outcomes. It is the first magnetic surgical system to receive CE Mark and FDA clearance. For more information visit www.levita.com.
1 “Key Statistics for Prostate Cancer | Prostate Cancer Facts.” American Cancer Society, 2019, www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.
2 “Surgery for Prostate Cancer.” American Cancer Society, 2017, www.cancer.org/cancer/prostate-cancer/treating/surgery.html.