Memic Innovative Surgery Ltd., Inc. received FDA approval for the Hominis® Surgical System on February 26th, 2021.
The Hominis Surgical System is an endoscopic instrument control system intended to control the Hominis robotic arms for use during single site, natural orifice laparoscopic assisted benign transvaginal surgery. Intended uses include: salpingectomy, oophorectomy, adnexectomy, ovarian cyst removal, and total benign hysterectomy with or without salpingectomy or salpingo-oophorectomy. Hominis utilizes two robotic arms that allow the surgeon to manipulate tissue and deliver monopolar and bipolar energy. The system utilizes a proprietary trocar and a third party laparoscope to obtain access to transvaginal anatomy.
Designed to provide improved ergonomic capabilities while keeping cost and footprint to a minimum, Hominis is the only FDA authorized product for transvaginal robotic surgery.
The FDA has evaluated safety and effectiveness of the Hominis platform in a study of 30 patients undergoing transvaginal surgery for benign conditions. Using the Hominis system, all patients had successfully performed procedures without the need to convert to open or laparoscopic approaches. Observed adverse outcomes included minor blood loss, urinary tract infection, and delayed healing of the vaginal cuff.
The FDA concluded that this device is substantially equivalent to generic electromechanical surgical systems for transluminal approaches.
The Hominis Surgical System is indicated for use in adult patients for the following benign procedures:
- Total Benign Hysterectomy with Salpingo-Oophorectomy
- Total Benign Hysterectomy with Salpingectomy
- Total Benign Hysterectomy
- Ovarian cyst removal