Evaluation: Medtronic Signia Stapling System Powered Endoscopic Linear Surgical Stapler
November 30, 2018 | Evaluations & Guidance
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- The Signia Stapling System, in conjunction with Medtronic's endoscopic stapling reloads (including Endo GIA Universal straight and articulating reloads, and all Tri-Staple reloads), is intended to simultaneously staple and cut tissue for resection, transection, or creation of anastomoses via a battery-powered firing system during either open or minimally invasive procedures.
- The Signia Stapling System includes both single-use and multi-patient-use components. This necessitates a different workflow than clinical teams might be accustomed to with disposable stapling, including the aseptic transfer of a reusable powered handle into a disposable power shell; in contrast, disposable stapler requirements include only a stapler handle and unboxing and attaching the reload. Note that Medtronic refers to this system as a "smart stapling platform" rather than a "powered stapler." However, as the device is battery operated, for the purposes of this Evaluation we consider it to be a powered stapler.
- Major device components and software features:
- Signia power handle—a 1.9 lb sterilizable (steam and ethylene oxide EtO), multi-patient-use (up to 300 procedures) handle that allows for ambidextrous device controls including shaft rotation, jaw closing (compression) and opening, end-effector articulation, knife advancement, and knife retraction. It also provides user feedback via an LED display that communicates system status including battery level, reload cartridge type and status (i.e., fired or unfired), power handle status (e.g., number of times fired and remaining uses), and adapter and shell installation instructions. The power handle features an adaptive firing algorithm that varies the speed of firing depending on the tissue resistance; when used with Tri-Staple 2.0 Intelligent Reloads, the power handle provides the operator with a user interface to indicate which of three zones of firing speed the stapler is encountering.
- Signia power shell—a sterile, disposable, clear clamshell into which the power handle is inserted. It is intended for single-patient use, and the power handle cannot be used without a power shell.
- Signia adapter—a sterilizable (steam and EtO), multi-patient-use (up to 50 procedures) accessory that snaps into the power shell and accepts all available Medtronic Endo GIA and Tri-Staple reloads.
- Signia reusable insertion guide—a tool used to help maintain the sterility of the power shell during power handle insertion. It must be cleaned and sterilized prior to each use.