[HSF] Interesting article (Myxo Ring)

[Nasser F. Abou'Seada]

very interesting Ani
your input, analysis, evaluation and prespective  would greatly enrich the
way to pick up on it .

Festive Greetings
NFA


On 12/9/08, Ani Anyanwu <anianyanwu at hotmail.com> wrote:
>
>
> The plot thickens:
>
>
> http://www.reuters.com/article/domesticNews/idUSTRE4B30GL20081204?feedType=RSS&feedName=domesticNews
>
>
> Apparently the Senate (or specifically Senator Grassley) is now
> investigating Edwards and the Myxo Ring has disappeared from Edwards USA
> website and news reports are now saying that device may not have been
> appropriately FDA approved. Strangely too the IMR ring has disappeared from
> the website also. Strangely though, the Geoform is still on the website. The
> question seems to center (as we discussed before though in relation to the
> Geoform) of the way some devices can be cleared by FDA  (without clinical
> trials or data) because the device is deemed a minor modification of a
> predicate FDA approved device.
>
> If indeed the FDA does claim to have been misled and says that these
> devices (Myxo ring and IMR ring) have been used without appropriate FDA
> approval then we can expect a Pandora's box to open...
>
> Ani
>
>
>
> > Date: Wed, 8 Oct 2008 19:43:50 -0500> From: ebender001 at me.com> To:
> OpenHeart-L at hsforum.com> CC: > Subject: [HSF] Interesting article> >
> http://www.theheart.org/article/909595.do> > Questions raised about
> Northwestern use of valve device; prominent surgeon> denies wrongdoing>
> October 7, 2008 | Shelley Wood> > Chicago, IL - Northwestern University is
> fending off criticism that one of> its star surgeons, Dr Patrick M McCarthy,
> used a device he invented before> it was formally approved by the FDA,
> without first telling patients he might> use it. The university, the
> manufacturer, and McCarthy himself all insist> that the device, known as the
> Myxo ETlogix annuloplasty ring 5100, was> commercially available at the
> time. But heartwire has confirmed that the FDA> is investigating the
> circumstances surrounding its use, and another> cardiologist at Northwestern
> has come forward saying she believed the device> to be investigational at
> the time it was used. One of the patients who> received the device is suing
> McCarthy and Edwards Lifesciences, the> manufacturer of the ring.>
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