Talk about Interventional (and Innovational) Radiology....Endovascular Medicine is amazing.
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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.
Transcatheter Valve for Congenital Defect
Transcatheter Valve for Congenital Defect
It's a paradigm shift
Re: Transcatheter Valve for Congenital Defect
Amazing news, but the most amazing is the HDE program. Could CCSVI intervenntions qualify inside this program?pairOdime wrote:FDA approved this device under the Humanitarian Device Exemption (HDE) program.
Re: Transcatheter Valve for Congenital Defect
Frodo, I second your question.frodo wrote:Amazing news, but the most amazing is the HDE program. Could CCSVI intervenntions qualify inside this program?pairOdime wrote:FDA approved this device under the Humanitarian Device Exemption (HDE) program.