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SureForm

SureForm
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SureForm

Product catalog summary
Introduction
SureForm staplers, integrated with SmartFire technology, represent a new generation of stapling devices designed to enhance surgical outcomes. These staplers are compatible with the da Vinci X® and da Vinci Xi® surgical systems, offering improved maneuverability and precision.

Specifications and Features
SureForm staplers feature a 120° cone of articulation, allowing for greater freedom in tissue approach and reducing the need for tissue manipulation. The SmartFire technology performs over 1,000 measurements per second to adjust the firing process, ensuring optimal staple formation and minimizing tissue damage.

Performance Comparison
Compared to other leading staplers like Endo GIA Ultra, SIGNIA, and Powered Echelon Plus, SureForm staplers demonstrate superior performance in forming staples across various tissue thicknesses. Testing shows higher rates of successful tissue approximation and consistent cut line lengths, particularly in thick tissues.

Precision and Stability
SureForm staplers apply less tension on target tissues and stress on surrounding tissues during positioning and clamping, as evidenced by benchtop surgeon evaluations. This precision is further supported by reduced tip movement during firing, enhancing stability.

Reload Specifications
SureForm 45 and 60 staplers offer different reload options, including White, Blue, Green, and Black, with each reload providing a new knife. The devices are designed for single-patient use and offer 12 fires per device.

Safety and Usage Information
While SureForm staplers are designed to improve surgical outcomes, potential risks include serious complications such as tissue injury and infection. The devices are intended for use in various surgical procedures, including General, Thoracic, Gynecologic, Urologic, and Pediatric surgeries.

Conclusion
SureForm staplers, with their advanced technology and design, offer significant improvements in surgical stapling performance, providing surgeons with enhanced control and precision.
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Catalog excerpts

SureForm-1

SureForm with SmartFire technology Achieve more with your stapler.

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Achieve more with your stapler SureForm™ is a new breed of stapler. At its core is SmartFire technology, which monitors tissue compression before and during firing, making automatic adjustments to optimize the staple line. A 120° cone of articulation gives you the freedom to approach tissue where it naturally lies, potentially reducing the need to pull it towards the stapler.1 When you choose SureForm staplers, you can reduce uncertainty and increase stapling performance like never before.1 1. Results from testing on file.

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Compatible with the da Vinci X® and da Vinci Xi® surgical systems

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More maneuverability A 120° cone of articulation gives you the freedom to maneuver your stapler and position it where you prefer. Utilize a greater range of motion than the human hand or leading laparoscopic staplers with SureForm staplers.* Powered Echelon Flex SIGNIA / Endo GIA Ultra * Compared to Endo GIA Ultra with Tri-Staple technology, SIGNIA with Tri-Staple 2.0 technology, and Powered Echelon Plus with GST as of March 2

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More intelligence With one press of a pedal you activate SmartFire technology, which measures tissue compression before and during firing. SmartFire technology uses more than 1,000 measurements per second* to make automatic adjustments to the firing process as staples are being formed and as the transection is being made. This advanced firing technology is easy to use and helps ensure a more consistent staple line, all while preventing damage across a range of tissue thicknesses.** ** Results from testing on file ** Compared to Endo GIA Ultra with Tri-Staple technology, SIGNIA with Tri-Staple...

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Percentage of optimally formed staples in thick tissue (>4mm)f Powered Echelon Flex with GST Endo GIA Ultra with Tri-Staple SIGNIA with Tri-Staple 2.0 t Testing performed with black reloads on in vivo porcine stomach tissue with both 45mm and 60mm devices. Sureform 60 is significantly better than Endo GIA and SIGNIA in thick tissue. Sureform 45 is significantly better than all the three staplers in thick tissue. Data on file as of March 2019.

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Successful tissue approximation rate* Powered Echelon Flex with GST t Testing performed with black reloads on in vivo porcine stomach tissue with both 45mm and 60mm devices. SureForm 45 & SureForm 60 are significantly better than Echelon Flex. Data as of March 2019.

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More consistency SmartFire’s automatic measurements and adjustments during firing help you maintain control of the tissue. This ensures cut line integrity is not lost, and the expected length of transection is achieved. These consistent results can help you avoid using an unanticipated reload, potentially reducing cost. Deliver a more consistent cut line length across thin and thick tissue.* Figure A: Average cutline length (60 mm staplers) 56 55 54 Tissue Thickness Powered Echelon Flex with GST Endo GIA Ultra with Tri-Staple SIGNIA with Tri-Staple 2.0 Figure B: Average cutline length (45 mm...

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More precision With the full cone of articulation and anvil centric design of SureForm™ staplers, you can position the device exactly where you want, minimizing tension on the target tissue and stress to the surrounding anatomy. Less tension on target tissue and less stress on surrounding tissue during positioning and clamping† Tension on target tissue 10 Stress on surrounding tissue 1.0 MPa Average tension applied to target tissue 0.9 MPa while positioning and clamping stapler 0.84 0.84 Measured in newtons as a unit of force Endo GIA Ultra SIGNIA with with Tri-Staple Tri-Staple 2.0 Powered Echelon...

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More stability during firing Powered Echelon Flex with GST SIGNIA with Tri-Staple 2.0 Endo GIA Ultra with Tri-Staple Average amount of tip movement during firing in a side-by-side benchtop test. Images are for illustration purposes only and are not to the exact size. * As tested in ex vivo surgeon evaluations. SureForm 60 and competitive 60mm stapler data displayed. SureForm 45 and SureForm 60 demonstrated significantly less tip movement during firing than Echelon Flex, SIGNIA, and Endo GIA. Data on file as of March 2019.

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Stapler specifications SureForm 45: 45 mm staple line / 40 mm cut line SureForm 60: 60 mm staple line / 55 mm cut line An anvil centric design Operates through a 12 mm cannula 12 fires per device Single patient use Reloads specifications White, Blue, Green, Black reloads 6 rows of staples New knife with every reload

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Purchasing information To contact a representative or receive additional information: Visit www.intuitive.com or call Intuitive Surgical Customer Service in the U.S. at 1.877.408.3872, in Europe at +41.21.821.2020 or +800.0821.2020 or in the rest of the world, 1.408.523.2100. SureForm 45 from Da Vinci Stapling SureForm 60 from Da Vinci Stapling SureForm 45 White Reloads SureForm 60 White Reloads SureForm 45 Blue Reloads SureForm 60 Blue Reloads SureForm 45 Green Reloads SureForm 60 Green Reloads SureForm 45 Black Reloads SureForm 60 Black Reloads

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Disclosure The comparative studies highlighted in this document were performed in a benchtop setting, in vivo, or in a virtual setting and were not statistically powered to show the differences seen. The significance level to detect statistically significant differences was set at p<0.05. Important safety information Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or...

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All Intuitive Surgical catalogs and technical brochures

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  2. Da Vinci Xi

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.