Johnson & Johnson Marks Milestone with First Clinical Cases of Ottava Surgical Robot

Johnson & Johnson (J&J) MedTech has announced the successful completion of the first U.S. clinical cases using its Ottava surgical robot, marking a significant advancement in the company's robotic surgery program. The milestone procedures, performed at Memorial Hermann-Texas Medical Center in Houston, Texas, involved minimally invasive gastric bypass surgeries and represent a crucial step towards J&J's goal of competing in the rapidly evolving surgical robotics market.

Ottava's Design and Capabilities

The Ottava system is designed to support a wide range of soft tissue procedures and specialties, including complex surgeries. Its innovative design features four robotic arms integrated into a motorized operating table, which can be folded and stowed underneath to maximize space in the operating room. This unique configuration allows the system to fit within nearly any operating environment, providing flexibility for surgical teams.

One of Ottava's key advantages is its ability to perform both laparoscopic and open surgeries, as well as hybrid combinations of the two approaches. The system's table can move in concert with the robotic arms, facilitating patient repositioning without significant interruption to the procedure. Additionally, Ottava exclusively utilizes surgical instruments from J&J's Ethicon division, ensuring compatibility and integration within the company's broader portfolio of surgical technologies.

Clinical Trial and Regulatory Path

J&J received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) in November, paving the way for the current clinical trial. The study, led by Dr. Erik Wilson, chief of minimally invasive and elective general surgery at UT Health Houston, aims to evaluate Ottava's performance in various general surgery procedures within the upper abdomen.

Upon completion of the trial, J&J plans to use the collected data to pursue a de novo clearance from the FDA. The company is seeking an indication that would cover multiple general surgery procedures, including gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia repair. While J&J has not disclosed the expected timing for their FDA submission, the successful completion of these first clinical cases represents a significant step towards market entry.

Competitive Landscape and Market Implications

The introduction of Ottava places J&J in direct competition with established players in the surgical robotics field, most notably Intuitive Surgical's da Vinci system. Other competitors include Medtronic, which is developing its Hugo robot for urology indications, as well as smaller companies like CMR Surgical and Moon Surgical, which have already secured U.S. authorizations for their respective systems.

J&J's entry into the soft tissue surgical robotics market with Ottava complements its existing robotic portfolio, which includes the Monarch robotic lung biopsy platform and the Velys robot for orthopedic applications. The company's focus on innovation in minimally invasive surgery aligns with the growing trend of robotic system adoption across various surgical specialties.

As the surgical robotics market continues to expand, J&J's progress with Ottava represents a significant development in the industry. The success of these initial clinical cases may have far-reaching implications for the future of robotic-assisted surgery and could potentially reshape the competitive landscape in the coming years.