Core Access Surgical Technologies Inc. received FDA approval for LevaLap Laparoscopic Access Device on February 23, 2022.
The LevaLap Laparoscopic Access Device is a sterile single-use device intended for use in the peri-umbilical region of the anterior abdominal wall. It is intended to aid in the safe insertion of a Veress needle as a means to introduce pneumoperitoneum during intra-abdominal laparoscopic procedures. The device consists of a clear hemisphere-shaped housing containing a port for connection to a standard operating room (OR) vacuum system and a septum for introduction of a Veress needle. The LevaLap Laparoscopic Access Device is intended to raise the abdominal wall above critical organs and vessels by means of negative pressure, thus creating an initial space prior to insufflation in preparation for laparoscopic access.
Non-clinical testing was conducted to verify that the LevaLap Laparoscopic Access Device performs as intended.
The FDA has determined this device is substantially equivalent to a predicate device, the Aragon Surgical LapCap.
The LevaLap Laparoscopic Access Device is intended for use in the peri-umbilical region during gynecologic and general surgical laparoscopic procedures.