Edwards says valve patients had low 30-day mortality
* 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) 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.
The company said the data demonstrated strong hemodynamics and valve performance, as well as freedom from structural valve deterioration.
Irvine, California-based Edwards competes with CoreValve, which was acquired by Medtronic Inc (MDT.N) in February. (Reporting by Debra Sherman in Chicago, Editing by Maureen Bavdek)
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