Updated: 04/02/2014 11:13 PM
Created: 04/02/2014 12:09 PM KSTP.com
By: Leslie Dyste
Wednesday at 10 p.m. on 5 EYEWITNESS NEWS Dr. Archelle Georgiou discussed Medtronic's aortic valve that she says even impressed the FDA.
The aortic valve is inserted using a catheter without cracking open the patient's chest. She says it's reduced patient death rates more than open-heart surgery.
This Medtronic valve has been available in Europe for several years and was approved in the U.S. last January, but for a narrower group of patients with extreme aortic stenosis.
A study is being submitted to the FDA seeking formal approval to treat a larger group of patients. "But, the bottom line is yes, its available now," Dr. Georgiou said.
In the study, 800 patients with severe aortic stenosis had an aortic valve replacement. Half of the patients had their valve replaced with the Medtronic valve, which is inserted through catheter in the groin. The other half of the patients had a valve replacement through open heart surgery.
"The rate of death at one year was significantly lower in the group with the Medtronic device than in those that had open heart surgery: 14.2 percent vs. 19.1 percent. That’s five more people who survived out of every hundred that had the procedure," said Dr. Gerogiou.
She says this is important because aortic stenosis is debilitating - 50 percent of patients with severe stenosis die within two years if they aren’t treated. But, 1/3 of patients are too high risk to have open heart surgery to replace the valve.
"This is a great alternative in people with severe stenosis," said Dr. Georgiou.