Medacta Group SA / Key word(s): Regulatory Approval
- Milestone achievement in orthopaedic technology further strengthens Medacta's profile
- New surgical platform has the potential to improve surgical efficiency with economic benefits to the healthcare system
- Enhanced visualization via augmented reality boosts Medacta's personalized medicine offering
CASTEL SAN PIETRO, 13 July 2020 - Medacta today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its NextARTM Augmented Reality based surgical platform for total knee arthroplasty (TKA) procedures.
The NextARTM TKA is the first application of a new platform technology, which will be extended to hip, shoulder and spine procedures, designed and engineered with Artificial Intelligence and Machine Learning that make pre-operative CT-based planning and analysis efficient and precise.
The NextARTM TKA Application has the goal to improve efficiency and precision in total knee replacement and deliver personalized planning, with low upfront capital investment required by clinics and hospitals, as well as economic benefits to the healthcare system through OR efficiency and low cost per procedure. This new platform will be an optimal solution particularly for U.S. ambulatory surgery centers (ASCs), which provide same-day surgical care.
The Augmented Reality glasses provided with the NextARTM Platform allow the surgeon to visualize surgical actions and information in real-time, directly on the operative field. This improves the user experience and helps the surgeon remain focused on the patient at all times.
"With enhanced visualization via augmented reality, the NextARTM Platform is an innovative and efficient tool for ultra-precise, patient-specific treatment," said Dr Michael McAuliffe (MBBS FRACS), an orthopaedic surgeon at St Andrew's Ipswich Hospital in Queensland, Australia, and a member of the expert surgeon panel that Medacta collaborated with to develop the NextARTM TKA Application. "With the NextARTM TKA Application, we are able to track 3D soft tissue behavior during a surgery in real time. This functionality is an exciting advancement from traditional computer-assisted or robotic-assisted surgical systems that only track the relative movement of the knee bones, not the actual soft tissue."
The NextARTM TKA Application, with a precise reconstruction of the patient bone morphology, allows direct tracking of the collateral ligaments and a 3D analysis of soft tissue behavior throughout the whole range of motion during surgery, bringing patient-specific ligament balancing to the next level.
In addition to advanced planning tools, Medacta has developed the NextARTM TS, a revolutionary infrared single-use tracking system that has the potential to vastly improve surgery efficiency while helping surgeons execute pre-op plans.
"The new NextARTM TKA Application allows for great precision and control, ultimately translating to great efficiency in the operating room," said Jonathan Vigdorchik, M.D., an orthopaedic surgeon at the Hospital for Special Surgery (HSS) in New York and collaborator on this platform. "Particularly in today's environment, as surgeons and health systems look to recover surgeries that were deferred during the COVID-19 pandemic, efficiency in the operating room will become even more crucial than before. The NextARTM Platform with its Single-Use Infrared Tracking System will be a valuable solution to meet these new levels of market demand."
The NextARTM TKA works in conjunction with the Medacta GMK Sphere Medially Stabilized Knee implant, which has been proven to facilitate restoration of natural patient-specific kinematics.
"We are proud to be part of the NextARTM Platform project that represents the next step forward for personalized medicine in orthopaedics," said PD Dr. med. Sandro Fucentese, Head of Knee Surgery at the Balgrist University Hospital and collaborator on this platform. "For many years we have been collaborating with Medacta in developing personalized solutions that have been relevant at the global level. The NextARTM Platform perfectly fits into this philosophy relying on a solid and established ecosystem and expertise."
Francesco Siccardi, CEO of Medacta, said: "Patients and surgeons are attracted by improved outcomes and innovation, the NextARTM Platform is one Medacta answer to the current race in orthopaedic technology and I am very excited about this milestone achievement. Requiring a very limited investment in capital equipment, the NextARTM Platform perfectly represents Medacta's commitment to develop solutions that are able to improve patient outcomes and healthcare system sustainability."
For more information on the NextARTM Platform, please visit nextar.medacta.com
End of ad hoc announcement
|Company:||Medacta Group SA|
|6874 Castel San Pietro|
|Phone:||+41 91 696 6060|
|Listed:||SIX Swiss Exchange|
|EQS News ID:||1091815|
|End of Announcement||EQS Group News Service|