Doesn't stop the device getting approved though. Look at all the orthopaedic implants that are approved based on being generally similar to another device, even if that original device has already been pulled from the market. Device approval pathway is much easier than for drugs. Sirtex FDA approval was post a trial of <150 pts. That's why uptake takes longer and further clinical trials were undertaken but it was still a billion dollar before those other trials readout
https://www.accessdata.fda.gov/cdrh_docs/pdf/P990065b.pdf
Weird analysis to be making with the systematic review as they are just lumping everyone together like there has been no change in standard of care in the last 2 decades.
Scientifically not a sound publication, but theoretically can't see how it shouldn't help LAPC, it's like brachytherapy and should act as a potentiator for the chemotherapy and should be an easier sell from that point of view and will give something for the gastroenterologists with ERCP training to do that is more consistent so that they can mount a business case for hospital lists for ERCP rather than random stents and sphincterotomies.
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Doesn't stop the device getting approved though. Look at all the...
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