FDA awards 1st GI Shaver EndoRotor market clearance: 4 key notes

The FDA awarded Interscope's EndoRotor System marketing clearance.

Here's what you need to know about the first gastroenterology-facing flexible shaver technology.

1. Physicians can use the EndoRotor System in colorectal surgery.

2. Clinical data shows incomplete resection of colorectal disease is a challenge with disease persistence rates rising to 30 percent, leading to an increased complication risk.

3. The EndoRotor is the first flexible microdebrider that physicians use in the digestive tract to remove diseased mucosa. The device performs tissue dissection, resection and retrieval in a single step, allowing disease removal without thermal energy.

4. Interscope CEO Jeffrey Ryan said, "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."

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