January 23rd, 2008—Aragon Surgical, Inc., a developer of surgical devices, announced that it has 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, failure to correctly position the needle, and anxiety for the surgeon... [PDF] Aragon Surgical's Press Release -
