Intuitive Surgical Receives FDA Clearance For First 60mm Stapler

Intuitive Surgical recently announced that the FDA granted clearance for the company’s fully wristed, 60mm stapler. SureForm 60, a single-patient use 60mm stapler, offers 120 degrees of fully wristed articulation — an industry first.

Surgeons control SureForm 60 through the da Vinci surgeon console, creating an immediate connection between clinical decision-making and instrument action. Combining da Vinci’s tremor filtration with SureForm 60’s tip stability and 120 degrees of articulation in all directions may help provide surgeons with precise stapler manipulation and placement. 

SureForm 60 uses SmartFire technology — integrated software that optimizes stapler and staple line performance. SmartFire measures tissue compression before and during staple firing, making automatic adjustments to the firing process as staples are formed and the transection is made. SmartFire makes more than 1,000 measurements per second, helping to ensure a more consistent staple line, while helping prevent tissue damage, across a range of tissue thicknesses. 

“Intuitive continues our minimally invasive innovation with our 60mm stapler, rooted in extensive research and development and an understanding of surgeons’ needs,” says Sal Brogna, Intuitive executive vice president and chief operating officer.

SureForm 60 has general, thoracic, gynecologic, urologic, and pediatric indications.  It is compatible with the da Vinci Xi and X surgical systems. The SureForm 60 extends the da Vinci stapling portfolio to cover all required staple line lengths. It expands and evolves Intuitive’s da Vinci stapling portfolio, which includes 30 and 45mm stapler instruments.