Merlin, gekkowolf: nope those examples can’t be applied here . It’s very likely those two devices you cite used evidence of equivalence to other devices already on market, which is allowed under CE directive, to get away with providing limited data and get CE. It’s in the MEDDEV guidance my friends. There are already other atrial shunts and embolic protection devices available it seems. But for oncosil device, no suitable equivalent. (And no, SRX SIRT isn’t the equivalent).
so no change here, despite the claims osl has pumped out over time about panco and which have been swallowed by the more gullible sections of the market, the osl device’s efficacy remains unproven - this is FACT. Only safety is reasonably confirmed. Every single efficacy endpoint in panco could have been 100% down to the strong chemo.
oh you’ll be pleased to know Celgene recently got their locally adv panc cancer chemo study published (Lancet , main author Professor Philip, can be found on line ). So lets get this right- Celgene gives 107 patients with local adv PC gemcit plus abraxane and gets 18.8 month median overall survival. Panco adds the oncosil device to gemcit plus abraxane and gets ....16 month survival. It’s a real head- scratcher! Wonder if this has caught the attention of BSI?
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