Intuitive Surgical's new da Vinci X Surgical System has won FDA clearance in the U.S.
“This new system enables access to Intuitive’s leading and proven robotic-assisted surgical technology at a lower price point,” said CEO Dr. Gary Guthart. “Customers around the globe have different needs from a clinical, cost, and technology perspective; Intuitive’s goal is to meet those needs by providing a range of products and solutions: the da Vinci X System helps us continue to do so.”
The da Vinci X System
got CE Mark in April.
At that time, Guthart stressed that, “our surgeon, hospital, and health care customers around the world told us that robotic-assisted surgery matters for their programs and their patients, while underscoring the importance of providing choice from a clinical, technological and cost standpoint.”
Despite the lower cost the new system works with Intuitive’s portfolio of robotic-assisted surgical technologies – and all its programs, support, services, and solutions.
This includes the same vision cart and surgeon console as the flagship product, the Xi.
The new system permits adding advanced capabilities, and provides “a pathway for upgrading” as needed to meet the demands of a growing practice.
“As customers’ needs grow, the da Vinci X System can grow with them. The da Vinci X System enables our customers to take immediate advantage of Intuitive’s full ecosystem of support and services,” stated senior vice president of U.S. sales, Henry Charlton.
The da Vinci X System “enables optimized, focused-quadrant surgery including procedures like prostatectomy, partial nephrectomy, benign hysterectomy and sacrocolpopexy, among others,” according the the company.
It has flexible port placement and 3-D digital optics, and uses “the same advanced instruments and accessories as Intuitive’s flagship system.”
The new system makes operating easier with setup technology that employs voice and laser guidance, has a drape design that makes prep easier and an integrated endoscope.
The da Vinci X System will be available for sale in the U.S. later this year.
In mid-2016 a multi-institutional study demonstrated the viability of using the da Vinci robotic surgery suite for hernia repair, and found that it decreased post-op complications and aids recovery.
The approach also saved money. “Decreasing length of stay, and complications translates to savings in health care expenditures,” Dr. Anthony Gonzalez, lead author and chief of surgery at Baptist Hospital of Miami
told HCB News at the time. “On average, each robotic procedure creates a savings of $2,000.”
In 2013 two insurance companies, Illinois Union Insurance Co. and Navigators Specialty Insurance Co., claimed that Intuitive had misled in its liability insurance applications, which the company disputed. The case has gone back and forth in the courts through late 2016, according to Intuitive's April, 2017, 10Q.
“Based on currently available information, the company does not believe the Illinois Union matter will have a material adverse effect on the Company's business, financial position, or future results of operations,” it wrote in its SEC filing.
