Aragon Surgical Inc. received FDA special 510(k) clearance allowing laparoscopic surgeons to use the company's novel LapCap with any length needle, allowing the LapCap to be used across the patient obesity spectrum, including in morbidly obese patients.
The initial step in laparoscopic surgery requires instillation of gas into the abdominal cavity, creating the space in which the surgeon operates (the pneumoperitoneum). In order to instill the gas, the surgeon blindly passes a 14 gauge needle through the abdominal wall, attempting to position the needle tip within the abdominal cavity without injuring intestines or blood vessels based on subtle tactile feedback. Blind needle passage is an inconsistent maneuver associated with risk of needle injury to intestines and vessels.
In the majority of laparoscopic procedures, the surgeon utilizes a needle that is 12cm in length. However, in some morbidly obese patients and patients with significant abdominal wall fat, the surgeon may select a 15 cm needle.
The LapCap allows laparoscopic surgeons to safely, rapidly and predictably pass the Veress needle through the abdominal wall and into the abdominal cavity. In a clinical trial, the LapCap initially allowed for correct needle positioning in 100 percent of patients, and there were no needle-related injuries.
The LapCap previously received 510(k) clearance for use with 12cm needles. With this new clearance, the surgeon may select the needle length for use with the LapCap.