FDA clears first flexible shaver device for GI endoscopy

CHICAGO — Interscope announced it has received FDA clearance for marketing the EndoRotor system, and the U.S. market launch coincides with Digestive Disease Week, at which the company will exhibit the device.

The EndoRotor is the first flexible microdebrider for the GI tract, and what sets it apart from existing instruments is its ability to perform single-step tissue dissection, resection and retrieval, allowing endoscopists to remove diseased mucosa without thermal energy, according to a press release. It was developed to help overcome the challenge of incomplete resection, as the rates of persistent colorectal disease are as high as 30% based on clinical data.

“It is vital during invasive procedures to have access to the proper instruments that help to facilitate the work that needs to be done,” Ramon Franco, MD, an otolaryngologist and co-founder and chief science officer of Interscope, said in the press release. “The wrong instrument can waste time, frustrate the endoscopist and increase the chances of a undesirable outcome. The EndoRotor was designed to make mucosal resection simple, allowing the endoscopists to concentrate on the other aspects of the procedures.”

The device received marketing clearance in the European Union in October 2015, and the company currently has distribution in 10 countries in Europe. Leading centers in Germany, United Kingdom, Netherlands, Switzerland and Austria currently use the EndoRotor to manage gastrointestinal mucosal disease, and post-marketing studies are ongoing in Europe, according to the press release.

Disclosures: Franco is employed by Interscope.