Edwards Reveals Sapien Launch Plans For Transapical Delivery Method

Edwards estimates that the approximately 20%-30% of patients who would otherwise qualify but can’t receive a Sapien valve because their femoral artery is too small would likely make good candidates for the transapical, through the ribcage, route.

Edwards Lifesciences Corp. plans to rapidly train heart teams over the next two quarters to support the transapical delivery of its Sapien transcatheter heart valve following the recent expanded approval by FDA.

The device gained PMA approval on Oct. 19 for use in patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical...

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