Intuitive Surgical has secured approval from the US Food and Drug Administration for its fully wristed 60mm stapler.
The FDA campus in New Hampshire Ave, Silver Spring, Maryland.
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,” said 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.
Intuitive Surgical is the pioneer and a global technology leader in robotic-assisted, minimally invasive surgery.
Intuitive develops, manufactures and markets the da Vinci surgical system. The company strives to make surgery more effective, less invasive and easier on surgeons, patients and their families.
There are several models of the da Vinci surgical system. The da Vinci surgical systems are designed to help surgeons perform minimally invasive surgery. Da Vinci systems offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance.
They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.
Source: Company Press Release.