Intuitive Receives FDA Clearance for 8 mm SureForm 30 Curved-Tip Stapler
December 15, 2021 at 08:45 am EST
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Intuitive announced that the U.S. Food & Drug Administration (FDA) cleared the companys 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. 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.
Intuitive Surgical, Inc. specializes in the design, manufacturing, and marketing of robotic surgical assistance video systems. The systems consist of a surgical console, arm, remote-controlled endoscope, and 3D visual immersion system. Net sales break down by activity as follows:
- sale of instruments and accessories (56.5%): primarily wrist cuffs;
- sale of robotic systems (27%): systems marketed under the da Vinci brand (1,264 units sold in 2022) and intended primarily for urological, cardio-thoracic, and gynecological surgeries;
- installation and training services (16.5%).
The United States accounts for 66.8% of net sales.