Aragon Surgical LapCap Receives FDA 510(k) Clearance With Expanded Indications for Use
Business Wire, Jul 10 2007, 6:00 AM EST - Aragon Surgical, Inc., a venture backed surgical device start-up company, announced today that it has received FDA clearance which significantly expands the indications and market for the Aragon Surgical LapCap(TM). The LapCap is the first PCAD(TM) (Pneumoperitoneum Creation Assist Device), an entirely new category of laparoscopic enabling products.
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 12cm-long 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.
The LapCap allows laparoscopic surgeons to safely, rapidly, and predictably pass the 12cm-long needle through the abdominal wall and into the abdominal cavity. In a human subjects clinical trial, the LapCap correctly positioned the needle in 100% of patients, and there were no needle-related injuries.
Originally indicated for use in gynecologic laparoscopic procedures based on a human subjects clinical trial, the recent FDA clearance expands LapCap indications to include all general surgery laparoscopic procedures.
"By adding general surgical laparoscopic procedures, we have more than doubled the size of the LapCap market," said Christine Cunningham, Aragon Surgical's Vice President of Marketing and Business Development. "The LapCap is now indicated to help surgeons and patients in 2.4 million cases annually in the U.S."
"With this clearance, the LapCap is now available to assist not only gynecologists, but also general surgeons and surgical specialists, as well as both female and male patients," said Dr. Peter Edelstein, a surgeon and President and CEO of Aragon Surgical.
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 with investments from Delphi Ventures and ONSET Ventures.
About Delphi Ventures
Delphi Ventures is a venture capital firm that has focused on early stage investing in medical devices and biotechnology for two decades. With more than $850 million in committed capital, Delphi Ventures has funded over 150 companies. More than 90% of their portfolio companies have either completed an initial public offering or have been acquired by a leading healthcare corporation. http://www.delphiventures.com
About ONSET Ventures
ONSET Ventures specializes in providing "venture craftsmanship" -- an ideal mix of start-up, follow-on, and intellectual capital to entrepreneurs and early-stage technology ventures, to help transform world-class ideas into sustainable and valuable businesses. The firm has backed over 100 companies since 1984 and now has more than $700 million under management. http://www.onsetventures.com