FDA Panel Votes To Extend Sapien Valve Indication To Include High-Risk Patients

“What does FDA’s diligence with this product say about European regulators who gave it the nod five years ago?”

In short

Earlier this week we discussed a litany of doubt, presented by FDA for its Circulatory Devices Expert panel to pick over. That article can be found here, and it detailed, among other issues, concerns about potential bias in patient populations being randomised between conventional valve surgery and use of Edwards’ Sapien Transcatheter and Transapical approaches, as the company sought to extend the indication for its use from the current inoperable patient to now include the high-risk patient group.

It seems the panel satisfied themselves that the benefits of the heart valve outweighed the risks for these patients as it voted 11-0 in favour of approval. The final decision will now rest with FDA itself, but it’s difficult to see the agency heading in the opposite direction.


Edwards Lifesciences Corporation announced FDA Advisory Panel’s favourable vote yesterday, which would, if subsequently approved, see the company’s Sapien transcatheter heart valve delivered via transfemoral and transapical approaches, indicated for the treatment of high-risk patients with severe, symptomatic aortic stenosis. The panel voted 11-0, with one abstention.

The Panel’s “brief Summary” published after the meeting can be found here.

Edwards submitted a Premarket Application (PMA) in April 2011 based on data from the high-risk cohort (Cohort A) of The PARTNER Trial. Cohort A compared the outcomes of patients at high risk for traditional open-heart surgery evenly randomised to receive either surgical aortic valve replacement or the Edwards SAPIEN valve via transfemoral or transapical delivery.

In November 2011, the FDA approved SAPIEN via transfemoral delivery for the treatment of inoperable patients with severe, symptomatic aortic stenosis.

Company comments

“We are very encouraged by the Advisory Panel’s strong recommendation for approval to expand the current indication for the Edwards SAPIEN valve to patients at high risk for surgery. A broader indication for high-risk patients would enable multi-disciplinary Heart Teams to choose the approach best suited to their patients’ needs, including for the first time a transapical delivery option,” said Michael A. Mussallem, Edwards’ chairman and CEO. “We look forward to working closely with the FDA during the review process, and thank the panel for their thoughtful analysis of The PARTNER Trial results.”

We say

We await the full proceedings of the meeting, although the short summary is already available. Given the significant number of concerns raised in FDA’s executive summary of the submission it is perhaps unsurprising to see the Panel stipulating further study requirements in order to iron out what the agency clearly saw as a few wrinkles in the original submission. That said, it’s pretty clear they liked what they saw.

Finally, and most strikingly perhaps, we need to remind ourselves that this product is currently on the market in Europe with indications broader than those being discussed here, which makes it either a telling example of European regulatory laxity or an indictment of US regulations for preventing a promising technology reaching the 15% of patients who risk death in conventional surgical aortic valve replacement.

And what does FDA’s diligence with this product say about European regulators who gave it the nod five years ago? Remember that the indication being sought here is the same as the one actually approved in Europe in 2007(!) on what was presumably somewhat thinner evidence base at the time.

It’s a cracking example of the regulatory conundrum and should be used as a case study as regulators both sides of the pond develop their own takes on future medical device regulatory requirements.

Just a reminder

The Edwards SAPIEN valve is currently an investigational device for the treatment of high-risk operable patients in the U.S.

Source: Edwards Lifesciences Corporation, Marketwire