Virtuoso Surgical, Inc., a Nashville-based company developing a groundbreaking, entirely new class of robotic tools for endoscopic surgery, announced that the Virtuoso Surgical Robotic System has received FDA Breakthrough Device Designation for bladder lesion removal via en bloc excision, positioning the company at the forefront of early diagnosis and innovative bladder cancer care.
Leveraging a patented surgeon-controlled system that utilizes needle-sized robotic arms, the device is designed to significantly enhance the precision and dexterity of minimally invasive surgery performed via rigid endoscopes, a major component of the global endoscopy market. Virtuoso addresses a significant clinical need for improved specimen quality and staging in bladder lesions, the majority of which are bladder cancer.
“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. Virtuoso is starting with the removal of bladder lesions, the first critical step in diagnosing, staging and determining the management for cancerous lesions,” stated Virtuoso Surgical CEO and urologic surgeon Dr. Duke Herrell.
Effective Diagnosis Compared to Current Endoscopic Approaches
Founded in 2016, Virtuoso Surgical is led by experts in surgical robotics, urologic surgery, engineering and AI, working together to transform patient outcomes by enabling surgeons to perform delicate procedures in previously inaccessible areas of the body.
The en bloc resection (intact specimen) technique, enabled by the Virtuoso system, preserves the integrity of the pathological specimen and increases the accuracy of cancer staging, resulting in more definitive diagnoses versus the standard transurethral approach TURBT (transurethral resection of bladder tumor). Recent randomized studies have shown that manually performed en bloc techniques can lower one-year cancer recurrence rates versus standard TURBT. However, the manual method is currently complex for surgeons to learn and perform, which limits widespread application in the U.S. and worldwide. With Virtuoso’s two instruments and robotic dexterity, the company aims to enable the widespread adoption of en bloc resection.
Recently, the Virtuoso robotic system facilitated a series of endoscopic bladder lesion excisions using the advanced en bloc technique performed by Dr. Jeremy Teoh, a world-renowned bladder cancer surgeon and researcher, at The Chinese University of Hong Kong (CUHK).
Dr. Jeremy Teoh commented, “The ability to perform an en bloc resection for bladder cancer with this level of robotic assistance is a game-changer even for an expert in the technique. This robotic approach has the potential to enable the widespread adoption of en bloc techniques, thereby minimizing local recurrence and providing a more definitive pathological specimen, which is crucial for guiding subsequent treatment decisions. We are extremely optimistic about what this technology means for the future of bladder cancer surgery and patient outcomes.”
FDA Breakthrough Devices Program Structure
The FDA Breakthrough Devices Program accelerates the development and review of medical devices that offer more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions. Qualifying technologies, such as Virtuoso Surgical’s system, benefit from prioritized regulatory interactions, more frequent feedback, and expedited assessment pathways to ensure rapid patient access once safety and effectiveness standards are met. This designation highlights the system’s potential to address critical gaps in bladder lesion removal and cancer care compared to current endoscopic approaches, such as TURBT.
Future Growth Plans
Virtuoso Surgical celebrates this significant milestone and looks forward to seeking FDA regulatory approval and partnering with clinicians to further validate the clinical advantages of its robotic platform through ongoing clinical studies and expanded patient access. Virtuoso has future plans to explore the use of this technology in urology and subsequently in various surgical specialties that utilize rigid endoscopic surgery, including gynecology, pulmonology, otolaryngology and neurosurgery.
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