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Intuitive Secures FDA Clearance for 8 mm SureForm 30 Curved-Tip Stapler


Intuitive (Nasdaq: ISRG) has today announced that the U.S. Food & Drug Administration (FDA) cleared the company’s fully wristed, 8 mm SureForm 30 Curved-Tip Stapler and reloads (gray, white, and blue) for use in general, thoracic, gynecologic, urologic, and pediatric surgery.

The 8 mm SureForm 30 stapler is expected to launch in the U.S. in 2022, with other countries to follow. It has been designed to help surgeons better visualize and reach anatomy through a combination of the 8 mm diameter instrument shaft and jaws, 120-degree cone of wristed articulation, and the curved tip. As it fits through the 8 mm da Vinci surgical system instrument cannula, the stapler allows different angles for surgeons to approach patient anatomy.

“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,” said Bob DeSantis, Intuitive’s executive vice president and chief product officer. “We continue to innovate our systems and instruments by listening to our customers and enhancing capabilities, products, and services.”

“Having an 8 mm diameter stapler option—especially during complex procedures—will give surgeons more choices to access target anatomy with confidence,” said Dr. William Tisol, a thoracic surgeon based in Wisconsin.

As with the other SureForm staplers, the 8 mm SureForm 30 Curved-Tip Stapler integrates SmartFire technology — software that optimizes staple line performance by measuring tissue compression before and during staple firing.

The SmartFire technology makes automatic adjustments to the firing process as staples are formed and the transection is made. The technology makes more than 1,000 measurements per second, helping achieve a consistent staple line.

Source: Intuitive.

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