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Aragon Surgical, Inc. LapCap Receives FDA Special 510(k) Clearance for Use With Longer Needles Used in Morbidly Obese Patients


1/23/2008 8:56:42 AM

PALO ALTO, Calif.--(BUSINESS WIRE)--Aragon Surgical, Inc., a developer of surgical devices, announced today 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.

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.

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.

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.

“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.“

About Aragon Surgical, Inc.

Located in Palo Alto, California, Aragon Surgical is a venture backed, market driven surgical device company that is developing and commercializing a variety of surgical instruments intended to reduce operative time and improve patient safety, benefiting both patients and surgeons. Aragon Surgical was founded in 2005 and are supported by investments from Delphi Ventures, ONSET Ventures, Bay City Capital, and Integral Capital Partners. Please visit us at www.aragonsurgical.com or call Customer Service toll free at (888) 207-2058.

Contacts

Aragon Surgical, Inc. Christine L. Cunningham, 650-543-3100 Vice President of Marketing & Business Development CCunningham@AragonSurgical.com



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