The strategic project leader for the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) initiative in the U.S., David Rattner, MD, served as a panelist at several sessions during the EAES congress in Prague.

NOSCAR is a joint initiative supported by the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) that each year awards grants for the development of techniques and technologies to advance natural orifice translumenal endoscopic surgery (NOTES).

A founding member of NOSCAR, Rattner is co-chair of the joint committee on NOTES for SAGES and ASGE and a founding member of the Center for Innovative Minimally Invasive Therapies .

He is chief of the Division of General and Gastrointestinal Surgery at Massachusetts General Hospital (Boston)

During a pre-conference work session in Prague, he told colleagues with the EAES Technology Work Group that NOSCAR is planning a clinical study for NOTES to produce "high-quality scientific data to inform the FDA that NOTES is safe and can be reasonably priced."

The study and other updates on developments for NOTES in the U.S. will be presented at the NOSCAR meeting in Boston July 9-11.

Rattner told Medical Device Daily the trial will be a non-inferiority model putting trans-orifice cholecystectomy up against gall bladder removal by conventional laparoscopy.

"We have to hit singles before we go for a home run," he said, adding that he believes NOTES will eventually prove to be an effective and safe procedure for more advanced surgeries, but that "we are doing gall bladder because that's what we have the tools and experience to do."

"NOTES will have a greater impact bringing less invasive procedures to thoracic surgeries, for example, or an ideal applications for colonic ressection," he said, agreeing with his European colleagues that for the moment, "we do not have the devices to do this totally with flexible endoscopy."

Rattner presented a review on NOTES platform developments for flexible and semi-rigid endoscopes that offer triangulation of working instruments such as the Transporter from USGI (San Diego), the Animbus from Karl Storz (Tuttlingen, Germany), the ENDO Samurai from Olympus Europa (Hamburg, Germany) and Direct Drive from Boston Scientific (Natick, Massachusetts).

"We are pleased to being going slowly and responsibly," he said. "If I were part of a major company, I may wish things were going faster, but we can not afford to have a disaster. In the US we have been responsible with no deaths and no complications."

"Right now there is not a killer application for NOTES, so unfortunately companies are not seeing a market," Rattner said. "Then there are the cost constraints, which in the U.S. could become an enormous barrier with [the coming of] healthcare reform, as these NOTES devices will add cost to procedures."

"In the U.S. it is going to be all about the dollars," he said, adding, "We'll know more one year from now with healthcare reform the direction that the FDA will take with regards to NOTES."

The NOSCAR study aims to add structured, scientific documentation to the discussion, he said, which could open the door for device development and more procedures.

"If the FDA insists on an IDE pathway for these devices, then we are in trouble," he said and the development of tools and procedures for NOTES may well shift to Europe, Israel and, notably, South America, where there has been significant clinical experience with NOTES."

— John Brosky, European Editor