Author(s): Timothy S. Snow, DO
Teleflex Medical, Inc. received FDA approval for the next generation Percuvance™ Percutaneous Surgical System on April 8, 2016.
The next generation Percuvance™ Percutaneous Surgical System is a percutaneous, micro-laparoscopic platform that combines a reusable handle with a low-profile instrument Shaft (2.9mm) and various 5mm End Effectors/Tool Tips. The benefits of this system include smaller incision sites (2.9mm), and a reduced need for ports during laparoscopic procedures.
The system consists of fourteen unique components, which are combined to create a multifunctional set of instruments for laparoscopic procedures. Components include two reusable Handles (ratcheted and non-ratcheted), a single-use Shaft (available lengths: 29cm and 36cm), and single-use Tool Tips: Scissors, Gripper Grasper, Johans Grasper, Maryland Dissector, Hook Cautery, Spatula Cautery, and Clip Applier.
Initial access is achieved without a trocar using the Introducer Tool Tip attached to the Shaft. Once inside the peritoneum, the Tool Tip is extracorporealized through a pre-inserted, central trocar and exchanged for another Tool Tip. A Seal Bridge is used to protect the trocar seal and maintain insufflation when used with a trocar to facilitate extracorporeal exchange.
Comprehensive bench testing has been successfully performed on this system, consisting of biocompatibility evaluation, functional verification, dimensional verification, and force verification. The resulting data found that the system performed equivalently or better than predicate systems. Design and usability validation testing consisted of surgeons assembling the system, performing laparoscopic procedure steps in a porcine model, and disassembling the system. The surgeons then completed a device usability questionnaire to evaluate system performance; the validation testing results were acceptable.
The FDA has determined this device to be substantially equivalent to predicate devices: Percuvance™ Percutaneous Surgical System, MiniLap® MiniPolar Electrocautery Instrument, and Hem-o-lok® Ligating Clip System.
Indications:
This system is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize, and deliver Hem-o-lok® ligating clips to soft tissue during laparoscopic surgery.
Contraindications:
- The device is not intended for use when endoscopic techniques are contraindicated.
- The Shaft component and Tool Tips provided are sterile and intended for single-use.
- The monopolar active Tool Tips are not intended for contraceptive coagulation of fallopian tissue but may be used to achieve hemostasis following transection of the fallopian tube.
- Hem-o-lok® ligating clips are not intended for use as a fallopian contraceptive tubal occlusion device and are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
