No matter how minimally invasive a procedure may be, patients generally don't like the idea of their surgeon feeling anxious about any part of it. And so reducing the risk of needle-injury — for the patient, but also alleviating a common anxiety for laparoscopic surgeons — is one large advantage of the LapCap, says its developer, Aragon Surgical (Palo Alto, California).
Aragon, a venture-backed surgical device start-up, recently received FDA clearance that it says significantly expands the indications and market for its LapCap, by assisting laparoscopic procedures.
The LapCap is the first Pneumoperitoneum Creation Assist Device (PCAD), which Aragon bills as an entirely new category of laparoscopic-enabling products.
Christine Cunningham, VP of marketing and business development for Aragon, told Medical Device Daily that currently for every laparoscopic surgery, the surgeon needs to create a pneumoperitoneum — a working space — by instilling gas into the abdominal cavity to "puff the belly up."
This, she said, involves the use of towel clamps to clamp each side of the belly button to lift up the abdominal wall so that the doctor can pass a 12 cm Veress needle through it, attempting to position the needle tip within the abdominal cavity without injuring intestines or blood vessels based on subtle tactile feedback.
This "blind" needle passage, as it is called, is a tricky and inconsistent method, Cunning said, and there are various adverse events associated with it, including injury of the patient's intestines or, worse, the aorta.
So the LapCap, Cunningham said, is a simple plastic dome designed to lift up the abdominal wall so the surgeon can pass the Veress needle without any risk of needle injury. From there the surgeon can continue the procedure as normal, she said.
"Everything else stays the same. It just takes some of the risk out of passing the Veress needle," Cunningham said.
In a human clinical trial, the LapCap correctly positioned the needle in 100% of patients, and there were no needle-related injuries, the company said.
Aragon said the LapCap, importantly, also reduces the surgeon's anxiety over this initial blind maneuver —and when communicated to patients, much to their relief.
Cunningham said the device was first indicated for use in gynecologic laparoscopic procedures, which is about 40% of the 2.7 million laparoscopic procedures done in the U.S. every year that require a pneumoperitoneum. The recent FDA clearance expands LapCap indications to include all general surgery laparoscopic procedures, she said, more than doubling the size of the LapCap market.
"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 Peter Edelstein, MD, a surgeon who is president/CEO of Aragon.
In March, Aragon purchased VeriSure (Palo Alto), which gave it acquisition of the LapCap (Medical Device Daily, March 14, 2007).
Aragon — founded in 2005 with investments from Delphi Ventures and Onset Ventures — is developing a variety of surgical instruments intended to reduce operative time and improve patient safety.
Cunningham said the company is currently working on developing a Series B round of fundraising.