UPDATE 2-Abbott's heart valve device proves safe,
UPDATE 2-Abbott's heart valve device proves safe, effective
UPDATE 2-Abbott's heart valve device proves safe, effective
An experimental, minimally invasive technique to repair the most common type of heart valve problem proved to be far safer and nearly as effective as open heart surgery, christmas decorationmeeting the primary goals of a pivotal study,#x researchers said on Sunday.
Abbott Laboratories (ABT.N) is hoping to use the data to win U.S. approval for the mitral valve repair device. Its MitraClip has been available in Europe for about 18 months.
In the first large trial of its kind, researchers compared the Abbott device -- delivered to the heart via a catheter through a blood vessel in the leg -- against open heart surgery to treat mitral regurgitation, or MR.
The primary safety goal of the study compared the number of major adverse events -- a composite of 12, including major stroke, re-operation of mitral valve, urgent cardiovascular surgery, heart attack, kidney failure, major bleeding, and death -- at 30 days.
Among patients who received the MitraClip,Buy in Global, 9.6 percent suffered major adverse events compared with 57 percent in the surgery group, a difference considered to be highly statistically significant. #xIn the surgery group, 42 of the 55 adverse events were major bleeding, researchers said.
Dr. Ted Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in suburban Chicago and one of the studies lead investigators, called it one of the best safety results he had ever seen in a heart procedure.
There were no deaths,christmas decoration heart attacks or major strokes among the clip patients in the study.
MR, which affects more than 8 million people in the United States and Europe, is marked by a faulty mitral valve that does not close tightly enough, allowing blood to flow backward in the heart.
It is a debilitating condition in which the heart's ability to function deteriorates over time, and can lead to serious heart problems or and death.
Analysts believe the device could win U.S. approval next year and become a $1 billion a year product for Abbott.
Effectiveness was measured by the lack of need for surgery for valve dysfunction at one year. Moderate to severe MR in patients with initial successful treatment and death were also measures of efficacy at one year.
The device proved effective in 72.4 percent of patients compared with 87.8 percent in the surgery group,#x falling within pre-specified parameters of non-inferiority, researchers said.
"This is a stunning difference in safety for an acceptable trade-off in efficacy for many patients," christmas decorationsaid Feldman, who presented the data at the American College of Cardiology scientific meeting in Atlanta.
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