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news.Aragon Surgical, a developer of surgical devices, has received FDA special 510(k) clearance that allows laparoscopic surgeons to use the company's novel LapCap with any length needle, across the patient obesity spectrum, including morbidly obese patients.
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The LapCap allows laparoscopic surgeons to safely, simply, 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% of patients, and there were no needle-related injuries. With this new clearance, the surgeon may select the needle length for use with the LapCap.
Peter Edelstein, president and CEO of Aragon Surgical, said: “Heavier patients also benefit from this new FDA clearance, as their surgeons can now rely on the LapCap to assist in blind needle passage just as they do in their less heavy patients.”