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Board index » Treatments » Chronic Cerebrospinal Venous Insufficiency (CCSVI)

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pairOdime
PostPosted: Mon Feb 07, 2011 2:36 pm 
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Location: WV
Talk about Interventional (and Innovational) Radiology....Endovascular Medicine is amazing.

<shortened url>

Medtronic Melody® Transcatheter Pulmonary Valve - H080002
New Humanitarian Device Approval

FDA approved this device under the Humanitarian Device Exemption (HDE) program.

The Melody valve comes in sizes 18, 20, and 22mm diameters and has a stent length of 28mm. The Medtronic Ensemble® Transcatheter Valve Delivery System is a catheter (long tube with small diameter) that helps guide the Melody into the heart. The Ensemble delivery system has catheters with balloon sizes of 18, 20, and 22mm.

The Melody is used to repair a stenosed (blocked) or regurgitant (leaky) pulmonary heart valve that has previously been replaced to correct congenital (birth) heart defects. The Melody is put in place without using open heart surgery and while the heart is beating.

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It's a paradigm shift
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frodo
PostPosted: Mon Feb 07, 2011 4:57 pm 
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Posts: 521
pairOdime wrote:
FDA approved this device under the Humanitarian Device Exemption (HDE) program.


Amazing news, but the most amazing is the HDE program. Could CCSVI intervenntions qualify inside this program?

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You can get a worldwide list of available sites for CCSVI at http://www.ccsviclinic.info
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HappyPoet
PostPosted: Tue Feb 08, 2011 9:10 am 
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frodo wrote:
pairOdime wrote:
FDA approved this device under the Humanitarian Device Exemption (HDE) program.


Amazing news, but the most amazing is the HDE program. Could CCSVI intervenntions qualify inside this program?

Frodo, I second your question.
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Board index » Treatments » Chronic Cerebrospinal Venous Insufficiency (CCSVI)

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