FDA committee recommends approval of new heart procedure - KTIV News 4 Sioux City IA: News, Weather and Sports

FDA committee recommends approval of new heart procedure


An experimental heart valve was recommended for approval by an FDA advisory panel recently. It can be inserted without open heart surgery through a catheter system, allowing patients a much quicker recovery.

Harold Schoendorf works out most days on this exercise machine in his apartment and enjoys a weekly swim. He turns 85 in November. "I don't go out and jog around the block but I'm capable of doing that. I can run up and down the stairs of this building here, which I couldn't do before," said Harold. Harold says he got a new lease on life in April 2008. That's when he became the first patient in the Southeast to get an experimental heart valve at the University of Miami Hospital. "It was a piece of cake to get a new aortic valve without having open heart surgery," said Harold. Since he had a quintuple bypass in the 80s, surgery would have been too risky. So this device was implanted via a catheter through an artery in the groin. "They collapse this little valve and they go through the femoral and drop it in . And I don't think the whole procedure took two hours. And that evening I was reading the paper and the next morning I wanted to go home," said Harold.

"When we treated Mr. Schoendorf within the first or 3 patients we knew this was going to be a dramatic breakthrough," said Dr. William O'Neill. It's been a little more than 3 years since Dr. William O'Neill implanted the first Sapien Hart Valve at U.M. Since then 145 patients have received this experimental device. Dr. O'Neill says there has been a lower number of complications as well.

The FDA will conduct a final review, but generally follows the recommendations of its advisory panels. If final approval is granted, it will become the first transcatheter valve available in the U.S.

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