Virtuoso Surgical Robot Wins FDA Breakthrough Nod

Virtuoso Surgical, a company developing a new class of robotic tools for endoscopic surgery, reported its Virtuoso surgical robotic system received U.S. Food and Drug Administration (FDA) breakthrough device status for bladder lesion removal via en bloc excision.

The device leverages a surgeon-controlled system that uses needle-sized robotic arms to enhance precision and dexterity of minimally invasive surgery performed with rigid endoscopes. The company said it addresses a clinical need for improved specimen quality and staging in bladder lesions, most of which are bladder cancer.

The en bloc resection preserves the integrity of the pathological specimen and increases accuracy of cancer staging, resulting in more definitive diagnoses versus the standard transurethral approach TURBT (transurethral resection of bladder tumor). Virtuoso Surgical said recent studies have shown manually performed en bloc techniques can lower one-year cancer recurrence rates versus standard TURBT.

The method is currently complex for surgeons to learn and perform, limiting wider application in the U.S. and across the globe. Virtuoso’s two instruments and robotic dexterity hope to allow widespread adoption of en bloc resection.

“Virtuoso is unlike any surgical robot available today, and our vision is to provide surgeons with unprecedented dexterity and control in rigid endoscopic surgery, which is a distinct set of procedures and approaches that have not yet benefited from robotics,” said Virtuoso Surgical CEO and urologic surgeon Dr. Duke Herrell. “Virtuoso is starting with the removal of bladder lesions, the first critical step in diagnosing, staging and determining the management for cancerous lesions.”

The company said it has future plans to explore this technology in urology and subsequently in various surgical specialties that use rigid endoscopic surgery, including gynecology, pulmonology, otolaryngology and neurosurgery.

In June, the Virtuoso platform made its clinical debut by facilitating a series of endoscopic bladder lesions using the en bloc technique.