The firm now expects to gain approval for the extreme-risk indication of its transcatheter aortic heart valve months earlier than earlier predicted following well-received pivotal trial data reported last week at the Transcatheter Cardiovascular Therapeutics meeting.

It’s the first time Society of Thoracic Surgeons and American College of Cardiology have ever filed for an investigational device exemption. The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.

With all the major clinical data from Edwards Lifesciences' closely watched PARTNER trial now out in the open, there is little doubt among clinicians and industry analysts that transcatheter aortic heart valve replacements will be a U.S. commercial reality in the near term.