[HSF] Geoform: A Flawed Concept?

[Ani Anyanwu]

Also another word of caution for Dr Bernstein and other forum members who use this device: looking through the FDA Manufacturer and User Facility Device Experience Database, there are so far five adverse events reported with the Geoform - all were ring explants for regurgitation done 2 to 11 months after original implant. I do not know how many of these rings Edwards has sold in the US but I suspect the explant rate is worse than seen with other rings, and also considering that many surgeons do not voluntarily report adverse device events to the FDA, these 5 cases are likely a gross under-representation of the problem.
 
Of course some will wonder how the Geoform (or any new ring) gets approved by the FDA without clinical data. The reason is that it is considered as equivalent or a modification of a 'predicate' device with a clinical track record - in this instance the CE classic ring. Because the Geoform is 'comparable' to the classic Carpentier ring in design, intended use, materials, and principal of operation the FDA approves it without requirement for clinical data (same applies to approval process of other rings such as etlogix and myxoring). It is interesting to note that cardiomyopathy was not mentioned as the indication for the Geoform in the FDA 510(k) approval (as this would mean a different indication from the predicate device and therefore need clinical testing). The stated indication  for Georform on the FDA application is 
"The Edwards GeoForm TM Annuloplasty Ring is indicated for the correction of mitral valve insufficiency where the lesions are not so severe as to require total valve replacement"
According to the descriptions by Edwards on the FDA application the ring could (like the classic carpentier ring) be applied to any mitral dysfunction (Type I, II or III) hence the ease of FDA approval.
 
Like Hal I suspect that as more of these adverse events pile up in the FDA database, Edwards will be under pressure to withdraw the device (rather than risk the embarrassment of an FDA recall which would have ramifications for all their products).
 
Ani
 
 



> From: Hgrmd at aol.com> Date: Thu, 6 Sep 2007 07:01:10 -0400> Subject: Re: [HSF] Geoform: A Flawed Concept?> To: OpenHeart-L at lists.hsforum.com> CC: > > Mark,> Glad you finally weighed in on the Geoform thread. Closing the > interscallop leaks is the difference between mild and zero MR, which, in the long run, > I think is vital to maintaining a durable repair for annular dilatation.> I caught a bit of hell when I posted that case. However, I've since heard > from a number of surgeons across the country about the early failure of that > ring. As Ani pointed out, the ring has no published track record, and none > of the valve mavens, other than its inventor, support its use.> > Hal> > > > ************************************** Get a sneak peek of the all-new AOL at > http://discover.aol.com/memed/aolcom30tour> _______________________________________________> OpenHeart-L mailing list> > Send postings to:> OpenHeart-L at lists.hsforum.com> > To UNSUBSCRIBE, to CHANGE email address, or to view archives:> http://mmp.cjp.com/mailman/listinfo/openheart-l> > All messages transmitted by the OpenHeart-L are subject to the policies and > disclaimers posted at:> http://www.hsforum.com/listdisclaim> -----------------------------------------
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