Authors: Sarah Pratt MD, David Pechman MD
Intuitive Surgical received FDA approval for the SynchroSeal and E-100 Electrosurgical Generator on November 14, 2019.
The SynchroSeal is an advanced bipolar surgical energy device for the da Vinci X® and Xi™ systems. It is an 8mm single-use instrument that has 60° of wristed articulation and a curved jaw designed to allow surgeons to precisely seal and transect tissue. The SynchroSeal also allows for rapid sealing and has dual sealing and cutting functions. It requires only a single pedal press as opposed to the two-pedal press needed with the Vessel Sealer Extend to achieve both sealing and cutting of the tissue. The speed at which the SynchroSeal achieves tissue sealing comes from the E-100 Electrosurgical Generator, the first generator developed internally by Intuitive. The only generator currently compatible with the SynchroSeal, it is designed to deliver high frequency energy to the SynchroSeal or the Vessel Sealer Extend to allow for more rapid function than with the ERBE VIO dV generator. It does not, however, support the standard monopolar and bipolar Intuitive instruments, or any third-party instruments.
The SynchroSeal was assessed with the testing of human factors, biocompatibility, sterilization, packaging and transit, verification, and validation in animal/cadaver models, including a chronic animal study. The instrument demonstrated that it is non-hemolytic, causes no intracutaneous irritation, skin sensitization or acute systemic toxicity, and is non-pyrogenic. The design attributes and physical dimensions of the instrument were found to have no negative impact on safety and effectiveness.
The FDA has determined that the SynchroSeal and the E-100 Electrosurgical Generator are both substantially equivalent to predicate devices.
The SynchroSeal can be used for grasping, dissecting, sealing, and transecting tissue. Of note, the SynchroSeal does carry a smaller target vessel size than its predecessor, targeting vessels 5 mm or less compared to the approved 7 mm or less for the Vessel Sealer Extend. This is due to the smaller jaw profile and high frequency cutting blade present in the SynchroSeal. The E-100 Electrosurgical Generator supports only the SynchroSeal and Vessel Sealer Extend devices, and is not compatible with other Intuitive monopolar or bipolar instruments, or other third-party instruments.