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Edwards says valve patients had low 30-day mortality

Wed May 20, 2009 10:30pm IST
 
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* 30-day follow-up show low mortality for Sapien patients

* Data collected from over 1,000 patients at 32 centers

CHICAGO, May 20 (Reuters) - Edwards Lifesciences Corp (EW.N: Quote, Profile, Research) said more than 1,000 European patients who had received its Sapien aortic heart valve using a nonsurgical alternative for implantation had low mortality after 30 days.

Edwards, the world's largest maker of heart valves, has pioneered a new way to implant the device using catheters that are threaded through the body and into the heart, eliminating the need for open heart surgery.

Edwards, which presented its 30-day results at an industry gathering in Paris, said those patients who had the heart valve delivered via the femoral artery, had a 30-day survival rate of 93.7 percent, while those who had the valve delivered via a small incision between the ribs had a 30-day survival rate of 89.7 percent.

Edwards said these results were better than it had predicted in this high-risk group, which is made up mainly of older, very sick patients.

Implant procedure safety with the Sapien valve was shown to have a 1.5 percent incidence of implanting the device in the wrong position, a 0.6 percent incidence of coronary obstruction, a 2.5 percent incidence of stroke, a 2.7 percent chance of needing surgery, a 7 percent chance of requiring a permanent pacemaker, and a 4.7 percent incidence of significant aortic regurgitation.

The data were collected at 32 European commercial centers from November 2007 to January 2009.

Edwards also presented the first complete six-month data for the 130 patients enrolled in the Partner EU clinical trial.  Continued...

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