Regulatory approval of the Hugo™ robot-assisted surgery system in Japan Provides access to the world’s third largest robotics market with approval for general surgery in the European Union and Canada Open specialty fast growing hernia
DublinAnd the October 19, 2022 /PRNewswire/ – Medtronic plc (NYSE: MDT), the leading global healthcare technology company, has announced three approvals to enter the global market and expansion approvals for its Robotic Assisted Surgery System (RAS).
The approvals include:
- European Conformity Mark (CE) permit for general surgery indication;
- health Canada License to show general laparoscopic surgery; And the
- Ministry of Health, Labor and Welfare (MHLW) Approval of Indications for Laparoscopic Urology and Gynecology in Japan.
New system approvals and indications have paved the way for significant access across EuropeAnd the North AmaricaAnd the Asia Expanding the benefits of minimally invasive surgery to new global audiences.
As a minimally invasive form of surgery, robot-assisted procedures provide patients with fewer complications, a shorter hospital stay, and a faster return to normal activities.2-4, †
General surgery, urology, and gynecology together account for more than 80% of all RAS procedures performed globally.1 General surgery is the fastest growing segment of robotic surgery. It includes many different surgical specialties including hernia repair, which is the fourth most common surgical procedure performed globally.1 Japan It is the third largest RAS market in the world today.1
“Getting these important approvals paves the way for our expansion into key robotic markets,” he said. Mike Marinaro, Senior Vice President and Head of Surgical Robotics, part of Medtronic’s Medical Surgical Group. “The Hugo RAS system is designed to address barriers to the adoption of robotic surgery, and these approvals are important steps in bringing the benefits of minimally invasive surgery to more patients in more places around the world.”
Medtronic’s expansion into surgical robotics represents a significant growth opportunity for the company and builds on more than 60 years of experience in surgical innovation and healthcare in partnership with physicians around the world.
The Hugo RAS system, in conjunction with Touch Surgery™ Enterprise, provides a smart, digitally enabled surgical experience, and is already being used in general surgery procedures in hospitals in Asia Pacific And the Latin america Regions. Procedures range from common to more complex and include cholecystectomy, inguinal hernia repair, gastric bypass and anterior inferior resection.
A modular system, Hugo combines wrist instruments, 3D visualization, and Medtronic’s Touch Surgery Enterprise, a surgical video capture and management solution, with dedicated support teams specializing in robotics software optimization, service and training. Touch Surgery Enterprise is the first-of-its-kind AI-powered platform that makes surgical video sharing simple and provides surgeons with a powerful new training tool.‡
Dr. said. Carla Peron, chief medical officer, surgical robotics at Medtronic. “Our team is pleased to begin partnering with more surgeons and clients to help build and develop robotic surgery programs in this very important area of healthcare.”
Hugo RAS is commercially available in certain geographies. Regulatory and status requirements in individual countries and regions will determine Hugo RAS market availability and approved indicators. In the United States, the Hugo RAS is a research device that is not for sale.
For more information visit medtronic.com/hugo.
†compared to open surgery.
‡ Touch Surgery™ Enterprise is not intended to direct surgery or aid in the diagnosis or treatment of a disease or condition.
- Based on internal estimates and Medtronic report, FY 2020 market model: procedural volume data.
- Fitch K, Engel T, Bochner A. Cost differences between open and minimally invasive surgery. Managed care. 2015; 24 (9): 40-48.
- Tiwari MM, Reynoso JF, High R, Tsang AW, Oleynikov D. Safety, efficacy, and cost-effectiveness of common laparoscopic procedures. Surgical endoscope. 2011; 25 (4): 1127-1135.
- Roumm AR, Pizzi L, Goldfarb NI, Cohn H. Minimally invasive surgery: minimal reimbursement? Examined six laparoscopic surgeries. Surg Innov. 2005; 12 (3): 261–287.
Bold thinking. bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the world’s leading healthcare technology company that boldly attacks humanity’s most challenging health problems through research and solutions. Our mission – to relieve pain, restore health, and extend life – unites a global team of more than 90,000 passionate people in 150 countries. Our technologies and treatments treat 70 health conditions and include cardiac devices, surgical robots, insulin pumps, surgical instruments, patient monitoring systems and more. Powered by our diverse knowledge, insatiable curiosity and desire to help all those who need it, we offer innovative technologies that are changing two people’s lives every second, every hour, every day. Expect more from us as we enable insight-based care, experiences that put people first, and better outcomes for our world. In everything we do, we engineer extraordinary. For more information about Medtronic (NYSE: MDT), visit www.Medtronic.com And follow Medtronic on Twitter and LinkedIn.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from the expected results.
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