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We also note that the device associated with this procedure (AGENT TM Paclitaxel-Coated Balloon Catheter) received device pass-through status effective January 1, 2025 (89 FR 91434 through 91439)

I think eventually were going to need to do complication-specific clinical trials, as I mentioned, where its the improvement in the complication is the primary outcome measure, not amount of weight loss per se

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