Johnson & Johnson MedTech completes first cases with OTTAVA Robotic Surgical System
Upon completion of the study, the company plans to submit the OTTAVA system for De Novo authorization in the United States.
New Brunswick: Johnson & Johnson MedTech has completed the first cases in the clinical trial for the OTTAVA Robotic Surgical System. The cases mark the first clinical experience with the OTTAVA System.
Dr. Erik Wilson, Chief of Minimally Invasive and Elective General Surgery UT Health Houston and the lead investigator for the clinical study, performed Roux-en-Y gastric bypass surgery using the OTTAVA Robotic Surgical System at Memorial Hermann-Texas Medical Center.
“Surgical robotics is at the forefront of innovation in minimally invasive surgery,” Dr. Wilson said. “I am proud to have performed the first clinical study cases with OTTAVA and potentially help advance the standard in surgical robotics.”
OTTAVA is designed as a multi-specialty soft-tissue surgery robot, supporting a broad range of procedures across patient anatomy and surgical specialties, including the most complex surgeries that require a multi-quadrant approach.
"Data from this investigation aims to support the system’s ability to perform a variety of procedures," the release stated.
Upon completion of the study, the company plans to submit the OTTAVA system for De Novo authorization in the United States, targeting an indication covering multiple procedures in general surgery within the upper abdomen, such as gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.
“We are proud to reach this important milestone in our robotic surgery program,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “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. Our people work side-by-side with surgical teams in ORs around the world every day to raise the standard of care for patients and deliver what’s next in surgery.”
Johnson & Johnson MedTech’s OTTAVA system received investigational device exemption (IDE) approval from the U.S. FDA in late 2024.
“As a company operating at the intersection of biology and technology, clinical evidence generation is the core of our innovation programs to advance surgical technology for patients,” said Peter Schulam M.D., PhD, Chief Scientific Officer, Johnson & Johnson MedTech. “Through this clinical study, we are proud to be partnering with surgeons to gather evidence and support the ongoing pursuit of scientific study for the advancement of robotic-assisted minimally invasive surgery.”
The OTTAVA robotic system is under development and is not authorized to be marketed or sold in any market.
