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FDA Reviewing the Safety of New Heart Valve Replacement Procedure

June 15, 2012

The US Food and Drug Administration (FDA) is currently working to determine how safe a new synthetic heart valve may be for a wider range of patients. According to the Denver Post, the valve is currently used in patients whose health does not allow for open-heart surgery.

The valve is inserted in the heart through a small incision between the ribs and is then attached to the heart through an artery, versus opening the entire chest cavity.

New research has shown the new valve may be just as effective in healthier patients who would still be at high risk for open-heart surgery, such as the elderly or diabetics. The study showed a slightly lower mortality rate in those undergoing the new procedure as opposed to more invasive surgeries.

Opponents of the new valve have reported a higher risk of stroke in patients undergoing the new procedure after one month, causing some experts to believe it could lead to defective medical product claims. Reports also show that approximately half of patients that received the new valve have suffered leaking, which can cause blood to flow back into the heart and is a potentially lethal issue.

The Denver Personal Injury Lawyers with the McDivitt Law Firm support advances in medical technology, but would also like to remind patients to ask doctors plenty of questions and discuss as many alternatives as possible before undergoing any kind of serious medical procedure.

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