Intuitive (NSDQ:ISRG) announced today that it received FDA clearance for its SureForm stapler and reloads for use in surgery.
Sunnyvale, California–based Intuitive said the fully wristed, 8 mm SureForm 30 curved-tip stapler and reloads (gray, white and blue) are for use in general, thoracic, gynecologic, urologic and pediatric surgery.
It aims to help surgeons better visualize and reach anatomy by combining the 8 mm diameter instrument shaft and jaws, 120-degree cone of wristed articulation and the curved tip. As the stapler fits through the 8 mm da Vinci surgical robot instrument cannula, it allows different angles for surgeons to approach patient anatomy.
The 8mm SureForm 30 curved-tip stapler also integrates SmartFire software for optimizing staple line performance by measuring tissue compression before and during stapling.
According to a news release, the company expects to launch the 8 mm SureForm 30 stapler in the U.S. in 2022, with launches in other countries set to follow.
“In working with our customers, we identified an opportunity to provide better access and visibility during stapling procedures. The 8 mm SureForm 30 curved tip stapler achieves this while providing stapling performance surgeons have grown to trust,” Intuitive EVP & Chief Product Officer Bob DeSantis said in the release. “We continue to innovate our systems and instruments by listening to our customers and enhancing capabilities, products, and services.”