·   Log in

Melody transcatheter valve a non-surgical option for congenital heart disease, says Medtronic

Tagged with: ,
Tuesday, January 26, 2010, 19:30 This news item was posted in medical devices category and has 0 Comments so far.

Headquartered in Minneapolis, Medtronic, Inc is the global leader in medical technology.
Melody Transcatheter Pulmonary Valve by Medtronic, Inc has been approved by U.S. Food and Drug Administration.

Melody Transcatheter Pulmonary Valve is the first transcatheter heart valve to receive US FDA approval.

Melody Transcatheter Pulmonary Valve requires only a small incision as it is delivered through a catheter.

Melody valve will benefit children and adults who are born with a malformation of their pulmonary valve, which is the valve between the heart and lungs, Medtronic said.

These patients often require open-heart surgery to restore effective blood flow to their lungs.

Currently, the only way to repair or replace a failed pulmonary valve conduit was through additional surgeries.

More than 1,100 patients worldwide have already received a Melody valve, a Medtronic release said.

“The Melody Transcatheter Pulmonary Valve is a significant technological breakthrough and offers a reprieve for many patients with congenital heart disease – many of whom are young and will require several heart surgeries over their lifetime,” stated pediatric cardiologist Dr. William E. Hellenbrand of the NewYork-Presbyterian Morgan Stanley Children’s Hospital and Columbia University Medical Center.

In October 2006, the Melody valve became the first transcatheter valve to receive regulatory approval anywhere in the world when it received the CE (Conformité Européenne) mark. It is now approved by the FDA for use in the United States under Humanitarian Device Exemption (HDE), a special regulatory approval for treatments intended for fewer than 4,000 U.S. patients per year. HDEs are granted for medical devices that have demonstrated reasonable safety and probable benefit, but not clinical effectiveness.

Headquartered in Minneapolis, Medtronic, Inc is the global leader in medical technology.

Scroll down to comment on this story
You can leave a response, or trackback from your own site.

Leave a Reply