J&J MedTech Completes First Clinical Cases with Ottava Surgical Robot

Johnson & Johnson MedTech has announced the successful completion of the first U.S. clinical cases using its Ottava surgical robot system. This milestone marks a significant step forward in the company's robotic surgery program and highlights the potential for advanced surgical technologies to transform patient care.

FDA Approval and Clinical Trial Launch

The U.S. Food and Drug Administration (FDA) granted approval last fall for J&J to initiate human trials of the Ottava system. This innovative platform is designed to accommodate both laparoscopic and open soft tissue surgeries, as well as hybrid approaches combining the two techniques.

The first clinical case, a minimally invasive gastric bypass procedure, was performed at Memorial Hermann-Texas Medical Center in Houston. This Roux-en-Y procedure, which creates a smaller stomach pouch connected to the small intestine, showcases the system's capabilities in complex abdominal surgeries.

Ottava's Unique Design and Capabilities

Ottava represents a significant advancement in surgical robotics, with several key features that set it apart:

1. Versatile Integration: The system is designed to fit within nearly any operating room, offering flexibility for various surgical settings.

2. Innovative Arm Configuration: Four robotic arms are incorporated into a motorized table, which can be folded and stowed underneath when not in use.

3. Dynamic Patient Positioning: The table can move in concert with the robotic arms, allowing for patient repositioning without interrupting the procedure.

4. Exclusive Instrumentation: Ottava will utilize instruments exclusively from J&J's Ethicon division, ensuring compatibility and optimized performance.

Future Regulatory Pathway and Clinical Applications

Following the completion of this initial study, J&J plans to leverage the data to pursue a de novo clearance from the FDA. This regulatory pathway could potentially lead to approval for multiple general surgery procedures in the upper abdomen, including:

• Gastric bypass operations
• Sleeve gastrectomies
• Small bowel resections
• Hiatal hernia repairs

Hani Abouhalka, group chairman for surgery at J&J MedTech, emphasized the significance of this milestone, stating, "Ottava is a key innovation in our portfolio of advanced surgical technologies—all of which are designed to transform the surgical experiences across all surgery."