Johnson & Johnson MedTech, a global leader in cardiovascular, orthopaedic, surgery and vision solutions, today announced that the U.S. Food & Drug Administration (FDA) has approved the OTTAVA™ robotic surgical system investigational device exemption (IDE), which allows the clinical trial to begin at U.S. sites. The Company will now prepare clinical trial sites to receive OTTAVA systems, enroll patients, and begin surgical cases.
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News From Johnson & Johnson MedTech
Transmitted by PR Newswire for Journalists on November 12, 2024 08:00 AM EST
Johnson & Johnson MedTech Receives IDE Approval for OTTAVA™ Robotic Surgical System
Company prepares to support clinical trial in the United States
NEW BRUNSWICK, N.J., Nov. 12, 2024 /PRNewswire/ — Johnson & Johnson MedTech, a global leader in cardiovascular, orthopaedic, surgery and vision solutions, today announced that the U.S. Food & Drug Administration (FDA) has approved the OTTAVA™ robotic surgical system investigational device exemption (IDE), which allows the clinical trial to begin at U.S. sites. The Company will now prepare clinical trial sites to receive OTTAVA systems, enroll patients, and begin surgical cases.
Johnson & Johnson MedTech is building on its global portfolio of surgical technologies to advance OTTAVA and help surgical teams and hospitals provide more patients with the benefits of robotic surgery. The system is designed to address unmet needs that persist in robotic surgery today, while driving choice and competition in an underpenetrated and high-growth market.
„We are bringing the best of J&J MedTech’s surgery expertise to the OTTAVA system and taking a holistic view of the science of surgery to enable new experiences across all surgical modalities in service of patients around the world,“ said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. „Meeting this milestone brings us a step closer to delivering on our promise to make technology more human, care more adaptive, and people more connected so that surgery works better for everyone.“
„We are excited about reaching this important milestone and progressing our differentiated general surgery robotic platform for the benefit of patients and surgeons,“ said Rocco De Bernardis, President, OTTAVA, Johnson & Johnson MedTech. „With approval to move to clinical investigation, our teams are focused on training clinical trial investigators and teams as they enroll patients and prepare for cases.“
A differentiated approach to robotic surgery
The OTTAVA System is designed to set a new standard for the modern operating room (OR) and transform the surgical experience. The system’s unique unified architecture, surgical instrumentation powered by Ethicon expertise, and Johnson & Johnson MedTech’s digital ecosystem are intended to provide versatility to meet the needs of each patient’s care and each surgeon’s clinical approach.
The OTTAVA system features four, low-profile robotic arms incorporated into the operating table that can be stowed underneath. This unified architecture allows for a compact footprint designed to support robotic, laparoscopic, hybrid, and open surgery with more working space for clinical teams.
