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Re: None

Tuesday, 04/09/2019 9:24:45 AM

Tuesday, April 09, 2019 9:24:45 AM

Post# of 29432
TRXC/ISRG - head to head comparison data between Senhance and Da Vinci Xi. I am shocked about how much better Senhance did in the case series submitted to FDA for clearance (complications, length of hospital stay) because the Da Vinci surgeons presumably has lots of procedures already under their belts using the older Si system compared to Senhance users who included learning curve cases. See Table 4 in first link.

Senhance label expansion 510K data. (table 3 and 4)
https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180163.pdf

Da Vinci Xi 510K data.
https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170713.pdf

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