SEALED VASECTOMY PROCEDURE (SVP)®

The Signati Separo Vessel Sealing System is intended for use in a minimally invasive procedure to ligate and divide the vas deferens for male contraception. The Signati Separo(RF) Generator uses a proprietary algorithm to accurately deliver the bipolar energy and is to be used in conjunction with the Signati Separo specialized Vessel Sealing Handpiece device. Bipolar RF energy is generated and sent through the handpiece, where the energy is delivered to seal, ligate and divide the vas deferens.

Not approved by the Food and Drug Administration (FDA). These statements and the subject product have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. The device is not currently being marketed, nor is it available for sale in any country.

SEALED VASECTOMY PROCEDURE (SVP)®

The Signati Medical, Inc. SEALED VASECTOMY PROCEDURE (SVP)® seeks to improve the conventional vasectomy procedure. Like traditional vasectomy methods, the Signati Separo Vessel Sealing Handpiece procedure is conducted following clinical practice guidelines, where the vas deferens are removed from the scrotal tissue and sealed with the Signati Separo Vessel Sealing System. More specifically, the vessel sealing procedure includes the steps of:

• -Locating the vas deferens vessel within the scrotum.
• -Isolating the vas deferens in a fold of scrotal skin and removing it from the scrotum. The length of vas deferens is held by means of the Separo vas clamp. It is not required to strip back the sheath of the vas deferens like in a traditional vasectomy method. 
• -Positioning our patented vessel sealing handpiece device around the portion of the vas deferens vessel 
• -Engage foot pedal to apply cauterizing bipolar RF energy to the clamped portion of vas deferens vessel to thermally coagulate the vessel
• -If vas division is desired, the center section of the vessel can be excised using a secondary instrument, such as a scalpel.