Zimmer Biomet (NYSE:ZBH) said today that it won FDA 510(k) clearance for its Rosa Knee robotically-assisted total knee replacement surgery platform.
The newly cleared Rosa Knee system includes 3D pre-operative planning tools and real-time intraoperative data on soft tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis, the Warsaw, Ind.-based company said.
“Complementing the skill and expertise of the surgeon with Rosa Knee’s robotically-assisted technologies can improve accuracy, precision and consistency, which can improve patient satisfaction, clinical outcomes and efficiency. Rosa Knee functions as a surgical assistant that gives me the tools and real-time data to perform bone cuts with greater precision and improve patient-specific soft-tissue balancing and implant alignment, without losing my feel for a natural fit and flexion,” Dr. Christopher Cannova of the Washington Joint Institute at OrthoBethesda said in a prepared statement.
Zimmer Biomet said that the Rosa Knee also features its proprietary X-Atlas imaging protocol, which provides X-ray based preoperative imaging to create a 3D model and plan of the patient’s bone anatomy.
“We are excited for the launch of Rosa Knee, which brings together Zimmer Biomet’s robotics technology with our industry-leading Knee implants to help surgeons personalize surgical procedures for their patients. Zimmer Biomet is committed to leading the industry in bringing differentiated and holistic solutions to market that address the needs of our customers and improve patient outcomes,” orthopedics group prez Ivan Tornos said in a press release.
In November, Zimmer Biomet said that it won FDA 510(k) clearance for its Persona revision knee implant.
The post Zimmer Biomet wins FDA nod for Rosa Knee robotic surgical system appeared first on MassDevice.
from MassDevice http://bit.ly/2HxeW7S
Cap comentari:
Publica un comentari a l'entrada