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MicroPort Navibot enters the field of RAS with the SkyWalker, the company’s first robot-assisted platform for orthopedic applications.
Joe Darrah
August 23, 2022
3 Min Read
Image courtesy of RTimages / Alamy Stock Photo
The recent trend of robotic-assisted surgery (RAS) systems gaining a nod from FDA has continued this summer with the clearance for SkyWalker, the first robot-assisted platform to be released by MicroPort Navibot for orthopedic applications.
According to the company, FDA has awarded the SkyWalker device 510(K) clearance to offer a robotically assisted total knee replacement solution.
Compatible with the Evolution Medial-Pivot total knee system, SkyWalker reportedly has the technical advantages of precise operation and efficient coordination while placing an emphasis on safety both preoperatively and during surgery. Highlights of the new device include:
Preoperative: Surgeons receive assistance in providing personalized care through the formulating of implant plans that are based on CT scans of anatomical data prior to surgery, as well as specific implant data by the device’s planning system.
Intraoperative: Based on each patient’s alignment and anatomy, the SkyWalker system facilitates precise implant positioning during the surgical procedure to achieve the desired kinematics that are specific to each patient. SkyWalker then allows the surgeon to quickly proceed to resection through the use of a high-dexterity, lightweight mechanical arm provides improved surgical precision, accuracy, and efficiency.
The SkyWalker system also has the capability of equipping surgeons with information that can help to achieve the desired joint line reconstruction during a patient’s surgery while providing data to optimally balance soft tissues.
The company said it is also planning further development of additional orthopedic applications in the near future that will operate in conjunction with the company’s MicroPort Orthopedics chain of products for a more comprehensive orthopedic offering.
The company has also built a full technology research facility that features medical industry design capabilit, and benefits from core technological advantages of having a self-developed, high-dexterity, and lightweight mechanical arm combined with intelligent planning and navigation algorithms.
Long Lineage of Robotic Surgery
The SkyWalker now joins a growing list of RAS systems that have received FDA clearance over the past year in particular, including Xact Robotics and the Monarch by Johnson & Johnson/AURIS, reportedly the first and only multispecialty, flexible robotic solution for use in both bronchoscopy and urology.
FDA authorized its first approval of RAS systems in 2000, when the da Vinci Surgery System became the first system cleared for general laparoscopic surgery. According to David B. Samadi, MD, a renowned robotic surgical expert and urologist who specializes in robotic-assisted laparoscopic prostatectomy, the da Vinci RAS marked the first time FDA had approved an all-encompassing system of surgical instruments and camera/scopic utensils.
It was in the late 1980s, however, that a robot was first utilized during a surgical procedure when the PUMA 200 helped to perform a needle placement in a CT-guided brain biopsy, according to a report by the National Library of Medicine’s National Center for Biotechnology Information.
FDA noted the benefits of an RAS device have evolved to include the ability to facilitate minimally invasive surgery and to assist with complex tasks in confined areas of the body.
A recent study found that the use of robotic surgery for all general surgery procedures increased from 1.8% in 2012 to 15.1% in 2018.
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