Originally Posted by
wiggin
Cool! Are you in manufacturing, then, or R&D or what? Just guessing since you're in a cleanroom. (And GMP rules suck, as you will undoubtedly discover.)
I obviously don't know their technology with any level of detail (they're using some sort of electrospun scaffolds?), but I think there are real issues with the basic idea of bioresorbable CV devices. The mechanical environment is really critical for these devices, and bioresorbable scaffolds often have real issues getting the right elasticity/modulus in physiological loading regimes. This becomes a bigger issue as materials degrade (whose rate may be modified by the individual patient's disease state) and weaken. In theory it should be possible to repopulate and remodel the scaffolds at just the right rate to forestall these issues, but I question whether the technology exists to do that yet. There are also concerns re: cell organization and tissue deposition in vivo - you may get abnormal compliance developing if the valve doesn't grow perfectly after implantation, which can result in all sorts of serious flow problems (regurgitation, coarctation, etc.). Finally, blood-contacting materials are very susceptible to problems, and making something that will encourage cell infiltration and remodeling but won't cause, say, calcification, is a real challenge.
It's possible that Xeltis has solved these issues, which would be totally awesome. But most of the work I've seen on bioresorbable CV implants has been long on promise and short on results. I hope this is different!
