FDA Panel OK’s Edwards Sapien Heart ValveWednesday, July 20, 2011
A Food and Drug Administration advisory panel on Wednesday cleared a replacement heart valve made by Irvine-based Edwards Lifesciences Corp. for patients too sick to have open-heart surgery.
Edwards Sapien received a 9-0 favorable vote with one abstention.
The FDA generally follows the recommendations of its advisory panels and will make a final decision on Sapien at a later date.
Sapien is a replacement heart valve that’s threaded through the arteries through a catheter.
Edwards has sold Sapien in Europe since 2007 and could start selling it domestically in this year’s fourth quarter. Analysts have estimated the worldwide market for heart valves could ultimately grow to $2 billion in annual sales.
The panel’s vote came after long deliberations on clinical trial statistics and labeling, according to a Reuters report.
Panel members were concerned that the valve might be used in patients who were not ideal candidates and by operators and centers lacking sufficient experience, according to Forbes. Forbes also reported that the committee spent a good deal of time talking about the matters related to strokes .