Sunnyvale, Calif.-based Intuitive claims the EndoWrist stapler, used with its da Vinci Si and da Vinci Xi devices, as “the only devices of their type” with fully wristed articulation and technology designed to indicate that instrument jaws are adequately closed.
The EndoWrist stapler won 510(k) clearance from the FDA in October 2012 for the Si version, and in 2014 for the Xi version. Today Intuitive said both versions won CE Mark approval in the European Union in April and approval for the Si version in South Korea during the 1st quarter. An EndoWrist vessel-sealing device won a 510(k) nod in January 2012.
“The advancements we’ve made with the EndoWrist stapler further underscore our progress in offering a broad range of tools and resources to surgeons spanning several specialties, including general surgery,” marketing & new business development VP Dr. David Stoffel said in prepared remarks. “We continue to work to obtain approval to offer a full suite of stapler offerings for the da Vinci Xi in Korea and Si and Xi in Japan; clearances are expected later this year.”
“This is robotic-assisted technology at its best. The new robotic stapler allows for full surgeon control, with wristed functionality unlike other products in the market,” added Dr. Craig Rezac of the Rutgers Robert Wood Johnson Medical School. “The instrument’s internal feedback gives the surgeon the certainty that the stapling was performed in the best conditions. Overall, it is a significant enhancement to the technology.”
Last month, Intuitive tapped chief scientific officer David Rosa to be its new chief commercial officer and product development senior vice president Salvatore Brogna to be executive vice president of product operations, and named worldwide sales & marketing executive VP Jerome McNamara as senior advisor for commercial operations.
Rosa has been with the robot-assisted surgery device company since 1996, Intuitive said. Brogna’s tenure dates back to 1999, according to the company.
In April, Intuitive Surgical posted 1st-quarter results that failed to meet the mark on both the top and bottom lines, reporting bottom-line growth of 119.0% to $97 million, or $2.57 per share, on sales growth of 14.5% to $532.1 million for the 3 months ended March 31, compared with the same period last year.
Adjusted to exclude 1-time items, profits were $134.6 million, or $3.57 per share, a full 30¢ below expectations on Wall Street.