News | January 23, 2008

Laparoscopy Instrument Receives FDA Special Clearance for Use with Longer Needles

January 24, 2008 - Aragon Surgical Inc. has received FDA Special 510 (k) clearance allowing laparoscopic surgeons to use the company's LapCap with any length needle, allowing the instrument to be used on even morbidly obese patients.

The LapCap reportedly allows laparoscopic surgeons to safely, simply, rapidly and predictably pass the Veress needle through the abdominal wall and into the abdominal cavity to create the pneumoperitoneum. 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 15cm (longer) needle.

With this new clearance, the surgeon may select the needle length for use with the LapCap. "Surgeons now can confidently utilize the LapCap to assist them in blind needle passage in all of their patients, including their morbidly obese patients,” said Dr. Peter Edelstein, a surgeon, and president and CEO of Aragon Surgical. "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."

In a clinical trial, the LapCap initially allowed for correct needle positioning in 100 percent of patients, and there were no needle-related injuries.

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