Author(s): Andrew R. Luhrs, MD
Momentis Surgical Ltd. received FDA approval for AnovoTM Surgical System on October 2nd, 2024.
The Anovo Surgical System is a mountable electromechanical surgical system used in single-site surgical procedures through a transvaginal or transabdominal access point. The system consists of two Anovo instrument arms, Anovo Surgeon Console, and Anovo Robotic Control Unit.
The instrument arms are connected to the RCU, which is attached to a proprietary pedestal. The physician sits at the Anovo Surgeon Console, outside the sterile field, and controls the Instrument arms by manipulating the arms controllers. While manipulating the instrument arms, the physician views the surgical site through a standard OR visualization system using a standard commercially available laparoscopic camera inserted through an abdominal port and views the main user interface at the surgeon console.
Anovo™ Surgical System has performed extensive pre-clinical, human factors, and clinical performance testing. In a prospective multi-center study of 30 patients undergoing laparoscopic ventral hernia repair, all procedures were successfully completed with no conversions, device-related adverse events, or serious complications, demonstrating a favorable safety profile. Additional testing—including cadaver studies, usability assessments, bench and software validation, cybersecurity, electrical safety, EMC, biocompatibility, and sterilization—confirmed the system’s safety, reliability, and compliance with international standards.
The FDA has determined this device to be substantially equivalent to a predicate device, the Hominus Surgical System.
FDA approved Indications for use: Single site, natural orifice, transvaginal and transabdominal procedures in adult patients. To include the following: total benign hysterectomy with salpingooophorectomy, total benign hysterectomy with salpingectomy, total benign hysterectomy, salpingectomy, oophorectomy, adnexectomy, ovarian cyst removal, ventral hernia
