FDA Clears EndoRotor For Use In Airway Procedures Including Interventional Pulmonology

Interscope, Inc. announced the receipt of marketing clearance from the FDA for the EndoRotor® System to commercialize Pulmonary indications.  Interscope innovated the first flexible microdebrider for use by medical specialists in the digestive tract with reported results reducing the need for surgery in recurrent adenoma and removal of walled-off necrosis.  The company now looks to expand its offerings into the Pulmonary space.  Respiratory disease is affecting over 1 billion people worldwide and is considered to be one of the leading causes of death with 4 million people prematurely dying from chronic respiratory disease according to the WHO. Current airway disease interventions include lasers, microwave, and cryo-therapeutic devices.  These interventions are limited by their risks for airway fires and thermal damage to collateral tissue. The EndoRotor provides thoracic surgeons and pulmonologists expansive reach within their patients using the flexible microdebrider to facilitate disease removal without thermal energy.

Interscope CEO, Jeffery Ryan, stated, “We are extremely excited to be able to offer this therapy, building on the efficacy of other microdebrider OEMs whose devices were limited to the central airway.  EndoRotor provides customers with a means to access distal lesions using the proven concept of micro debridement.  We are excited to continue to build on the success of introducing the first-ever flexible shaver for pulmonary procedures. We are continuing to propel advancements in interventional endoscopic and minimally invasive care.”

Interscope previously announced the receipt of marketing clearance from the FDA for the EndoRotor® in 2018.  Meanwhile, the company has established commercialization in the USA for its Gastroenterology indication as well as distribution in European countries including direct sales in Germany and the United Kingdom.  The EndoRotor System is employed in the management of gastrointestinal mucosal disease at leading centers in Germany, United Kingdom, Netherlands, Switzerland and Austria. Multiple post-marketing studies are underway or have been completed in the USA and Europe to demonstrate EndoRotor’s value proposition to patients and physicians.

Source: Interscope Inc.

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