Johnson & Johnson MedTech recently completed the first cases in the clinical trial for its OTTAVA robotic surgical system.
Dr Erik Wilson, chief of minimally invasive and elective general surgery at 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 Centre.
Dr Wilson said: ‘Surgical robotics is at the forefront of innovation in minimally invasive surgery. 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 various procedures.
Upon completion of the study, the company plans to submit the OTTAVA system for De Novo authorisation in the US, 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.
Hani Abouhalka, company group chairman, surgery at Johnson & Johnson MedTech, said: ‘We are proud to reach this important milestone in our robotic surgery program. OTTAVA is a key innovation in our portfolio of advanced surgical technologies – all 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 US FDA in late 2024.
The system is designed to advance clinical innovation in general surgery, a stronghold for Johnson & Johnson MedTech’s broader surgery business.
OTTAVA is designed to address unmet needs that persist in robotic surgery today and support complex procedures.
The system’s unique unified architecture, surgical instrumentation powered by Ethicon expertise, and future connection to the Polyphonic digital ecosystem are designed to meet the needs of each patient’s care and each surgeon’s clinical approach.
Peter Schulam, chief scientific officer, Johnson & Johnson MedTech, said: ‘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. Through this clinical study, we are proud to partner with surgeons to gather evidence and support the ongoing pursuit of scientific study for advancing robotic-assisted minimally invasive surgery.’
Dr Eduardo Parra-Davila, colorectal and general surgeon at Palm Beach Digital Surgery Institute, said: ‘The industry needs a system that is adaptable, easy to use in any OR in the world, and maintains space in the OR. As surgeons, we need space to improve the workflow in the OR, increase safety, and enable 360-degree patient access so we can perform at the capacity we would like. That’s where OTTAVA comes in. OTTAVA offers a unique design that integrates into any OR and allows surgeons to do what they would like and know how to do, which is to focus on the patient.’
The OTTAVA robotic system is under development and is not authorised to be marketed or sold in any market.
For more information, visit http://thenext.jnjmedtech.com/surgical-robotics.
