Edwards tightens transcatheter valve stranglehold

Edwards Lifesciences looks set to hang on to its top spot in the transcatheter aortic valve implantation market with earlier than expected US FDA approval of its third-generation Sapien 3 valve. Edwards’ dominance should continue in spite of increasing competition from Medtronic, which has been gaining ground with its CoreValve device (see table below).

Now Edwards ought to pull away again. By 2020 the company is expected to bring in $1.95bn from its transcatheter aortic valve implantation (TAVI) devices, well ahead of Medtronic's $1.38bn, according to EvaluateMedtech data. And these figures could be due an upgrade: they are based on forecasts made before the Sapien 3 approval, which had been expected by the end of 2015.

The FDA go-ahead, which sent Edwards’ stock up 3% to $141.60, is in patients with severe aortic stenosis at high risk for open surgery. Unlike the original Sapien, the new device features an outer “skirt” to address the problem of paravalvular leak.

Lower risk patients

More approvals seem sure to follow, as Edwards has made no secret of plans to expand the market. It is already testing Sapien 3 in intermediate-risk patients, and presented promising results in this group at the EuroPCR meeting in Paris in May. Further into the future, the valve could also be used in low-risk patients, the biggest population.

Not to be outdone, Medtronic is also studying CoreValve in low and intermediate-risk patients.

No TAVI valves are approved in the US for intermediate-risk patients and, if Edwards does want to get a foothold in this market, Sapien 3 will need to show comparable – or better – results versus the current gold standard, open surgery.

US FDA-approved transcatheter heart valves
Company Device Approval date Indication
Edwards Lifesciences Sapien 3 Jun 2015 High-risk patients
Medtronic CoreValve Mar 2015 Valve-in-valve procedures in high and extreme-risk patients
Edwards Lifesciences Sapien XT Jun 2014 High-risk and inoperable patients
Medtronic CoreValve Jun 2014 High-risk patients
Medtronic CoreValve Jan 2014 Extreme-risk/inoperable patients
Edwards Lifesciences Sapien Oct 2012 High-risk patients
Edwards Lifesciences Sapien Nov 2011 Extreme-risk/inoperable patients

The intermediate-risk Sapien 3 data “appear impressive on the surface”, noted Wells Fargo analysts, but they added that the valve had not been directly compared against open surgery. Even so, using the imperfect comparison of open surgery results from other studies, Sapien 3 stacks up “quite favourably” with much lower 30-day mortality rates: 1.1% versus 5.4% with open procedures. Rates of stroke were similar and, in TAVI’s favour, hospital stays were shorter.

Sapien 3 is expected to get the green light in intermediate-risk patients in late 2016, but the low-risk group remains the biggest prize. This population makes up at least half of those undergoing surgical aortic valve procedures, with intermediate-risk patients accounting for 30-40% and high-risk ones around 10%. Edwards will undoubtedly focus on the low-risk group next as it seeks total TAVI domination.

To contact the writer of this story Madeleine Armstrong in London at [email protected] or follow @medtech_ma on Twitter

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