The FDA has granted De Novo authorization for Virtuoso Surgical’s Virtuoso Endoscopy System.
This is the first device in a new FDA classification for electromechanical surgical technologies aimed at endoluminal surgical procedures that use robotic instruments passed through an endoscope into the body.
The system is authorized for en bloc resection of bladder lesions in adult patients to obtain tissue samples, including detrusor muscle, to assist in the diagnostic evaluation of bladder cancer.
The FDA De Novo Authorization and new classification represents a growing class of robotic-assisted minimally invasive surgical innovations.
Bladder cancer is a common cancer especially in older men and can frequently recur, often proving deadly once it spreads beyond the bladder.
Treatment decisions from drug therapy placed in the bladder to radical bladder removal surgery start with the pathology and staging of the surgically removed tissue specimen. Roughly 84,530 Americans will be newly diagnosed with bladder cancer in 2026, according to the American Cancer Society. An estimated 75,000 established patients had a recurrence of their bladder cancer in 2021.
In the U.S., the first step in treatment for almost all bladder tumors is conventional transurethral resection of bladder tumor (TURBT), which typically removes tumors in fragments and disrupts the tumor tissue. En bloc resection can remove many of the tumors in one intact piece or larger segments, preserving the tissue and information pathologists need to stage the cancer.
"How well a bladder tumor is removed at the initial operation shapes how accurately we can stage the cancer and plan what comes next for the patient," said Sam S. Chang, M.D., M.B.A., Patricia and Rodes Hart Professor of Urologic Surgery and Chief Surgical Officer of Vanderbilt-Ingram Cancer Center, in a statement.
"Our current surgical instruments have not significantly changed in more than a century.”
Made of superelastic concentric nitinol tubes, Virtuoso’s patented robotic arms follow the surgeon's hand motions from a console. One arm can be used to lift and retract tissue and the tumor while the other dissects beneath it, bringing two-handed dexterity to endoscopic surgery through the urethra.
In the first 20 patients of the Virtuoso-sponsored VIABLE study detrusor muscle (the bladder's muscle layer, which pathologists need to see to stage the cancer) was present in 94% of removed lesions, exceeding the study's 60% performance goal and the median rate of approximately 70% reported across published studies of conventional TURBT.
Virtuoso plans a focused U.S. launch at leading urology centers in 2027. The company sees its miniature tools as a future platform for other procedures and surgical specialties that use rigid endoscopes and has completed early non-human feasibility work in gynecology, pulmonary procedures, and neurosurgery.