Interscope said today it won FDA 510(k) clearance for its EndoRotor endoscopic resection tool designed for gastroenterology and colorectal surgery.
The Worcester, Mass.-based medical device startup said that the EndoRotor is the 1st flexible microdebrider designed for use in the digestive tract to facilitate complete removal of diseased mucosa. The device performs tissue dissection, resection and retrieval in a single step, the company said, without the use of thermal energy.
“It is vital during invasive procedures to have access to the proper instruments that help to facilitate the work that needs to be done. 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,” Interscope co-founder & CSO Dr. Ramon Franco said in a prepared statement.
Interscope said it will launch the device at the Digestive Disease Week international conference in Chicago May 6 to the 9th.
“This latest milestone marks for our team the culmination of considerable efforts by Interscope and our partners. We thank the FDA and are proud of this achievement as we begin to replicate the success we’ve had in Europe in the US by introducing the first ever GI shaver while continuing to propel advancements in interventional endoscopic patient care,” Interscope CEO Jeffery Ryan said in a press release.
Last March, Interscope said it won CE Mark approval in the European Union for its EndoRotor. The company said the approval was possible due to support it received from the Massachusetts Manufacturing Extension Partnership, as well as the development effort with its resource partner Boston Engineering.