Edwards’ valve lead over Medtronic widens

Considering Medtronic is five times the size of Edwards Lifesciences it probably shouldn’t be receiving the drubbing on transcatheter aortic valves that its smaller rival is dishing out. Yesterday the smaller group secured expanded US approval of two versions of its Sapien valve – and Medtronic had to issue a warning after one its valve implantation devices was linked to 19 patient deaths.

This is a testament to specialisation: valves are pretty much all Edwards does, whereas Medtronic is involved in everything from bone grafts to deep brain stimulators. And Medtronic is expected to get expanded approval for its transcatheter aortic valve in a year or so. But that is a long time to have your rival with sole control of this wider market, and the new problems will not help. Goliath is not dead, but David is definitely ahead on points.

The extension of approval of Sapien XT and Sapien 3 to include their use in patients at intermediate risk from open heart surgery was widely expected following the positive results in this population posted four months ago, including those of the Partner II trial (ACC – Transcatheter aortic valves march on, April 4, 2016).

Payment

Approval is not so important in itself – many doctors were already using these valves off-label in this population – but for reimbursement purposes. Medicare will pay for Sapien 3 in intermediate risk patients immediately, Wells Fargo analysts wrote, adding that they believe it will be difficult for any centre in the US to not stock Sapien 3 and Sapien XT now they are the only devices with an intermediate indication.

The only ones for now, that is. In a year or so at least one variant of Medtronic’s competing CoreValve product ought to get the green light in intermediate-risk patients; various iterations of CoreValve are already approved in the US for high-risk and inoperable patients.

But that’s still quite a lag, especially considering the size of the new group of patients Edwards can now address. There are thought to be around twice as many intermediate-risk as high and extreme-risk patients in the US, meaning the approval essentially triples the market.

Unusually, Sapien 3 has secured the FDA’s blessing in intermediate-risk patients before getting European approval here: CE mark is expected early next year. Medtronic’s competing CoreValve Evolut R valve got CE mark for this group earlier this month.

Force

But the device used to deliver the Evolut R valve has run into trouble. This week Medtronic wrote to doctors to warn of a risk of vascular trauma in transcatheter aortic valve replacement procedures when the EnVeo R delivery catheter system is used. This followed an internal analysis which linked the product with blood vessel damage in 39 patients, 19 of whom died.

The product is not being withdrawn from the market as it is not itself faulty. Instead the blame has been placed on user error: Medtronic has advised cardiologists not to force the device if they feel resistance, and retract the delivery system if they see its tip bend unexpectedly on the angiogram.

The deaths sound alarming but this is nothing more than a minor setback unlikely to affect the sales of EnVeo R or the valve it delivers. But this has been another week when everything went right for Edwards and not so well for Medtronic. There have been quite a few weeks like that.

To contact the writer of this story email Elizabeth Cairns in London at elizabethc@epvantage.com or follow @LizEPVantage on Twitter

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