EP Vantage interview – Medtronic aims to build on CoreValve approval

The surprise US approval of Medtronic’s transcatheter aortic valve, CoreValve, last week allows the company to start seizing market share from the previous sole occupier, Edwards Lifesciences’ Sapien. Some estimates suggest that CoreValve’s market share in the region could top 30% by the end of the year thanks to its startlingly good clinical data and ability to treat a wider range of patients.

“It has come six months earlier than we had anticipated. This device can treat such a broad patient population in the US, it is very important for patients that otherwise don’t have a treatment option,” Rhonda Robb, general manager of catheter-based therapies at Medtronic’s structural heart business, told EP Vantage.

Larger yet smaller

In fact the approval concerned two devices: the 26mm, 29mm, and 31mm sizes of CoreValve and a smaller version called CoreValve Evolut, 23mm in diameter. Both are now cleared to treat patients who are at extreme risk for surgery – essentially, inoperable patients.

This has allowed Medtronic to get the jump on Edwards’ next-generation product, Sapien XT, US approval of which is expected mid-year, around the same time as CoreValve’s had been. But when XT gets the nod it is expected to be for use in both extreme and high-risk patients, giving it an advantage over CoreValve, which is not expected to gain approval in high-risk patients until mid-2015. These patients can undergo heart surgery but are at high risk of complications – a larger market for the device. When Sapien XT launched in Europe in 2010, it did indeed take share from Medtronic’s device.

Medtronic thus has five or six months to get cardiologists to embrace CoreValve before the scene changes again. “For the rollout we’re planning we’ll have to reach about 300-350 sites, and that will take place over the course of a couple of years,” Ms Robb says. The pivotal trial of the device means that around 60 US sites are already familiar with the product.

CoreValve’s US sales ought to reach $5m in the first quarter of this year, David Lewis, an analyst at Morgan Stanley, wrote, and Ms Robb says it will be priced at around the same level as Sapien.

Its suitability for patients who cannot be treated with Sapien is key to CoreValve’s appeal. “We learned from our clinical trial that many patients in the US actually require larger valve sizes than are available in the US today,” Ms Robb says. Neither Sapien nor XT are larger than 29mm.

Despite a wider range of sizes, the delivery system is smaller than Sapien’s. “The platform is also available on a 6mm [diameter] delivery system across all sizes meaning that patients with smaller vasculature can also have access to the device,” Ms Robb says. “If a patient has a particularly tortuous or complex anatomy, this device is very flexible in its ability to be placed. I also hear feedback from physicians with patients with severely calcified leaflets where this device is very appealing.”

Valve philosophies

As might be expected, Ms Robb plays down the threat from Sapien XT. “XT is very similar to Sapien; it’s a balloon-expandable valve. Fundamentally our valve philosophies are very different. I continue to be very optimistic with the performance of CoreValve, particularly on stroke mortality, vascular complications and paravalvular leak.”

Medtronic is working on a next-generation version of its own. “We have started a clinical trial in Europe on Evolut R, a self-expanding Nitinol-framed superannular valve – elements that we think are critically important for these patients. This new device will also be fully recapturable,” Ms Robb says. “We have four clinical trial sites underway, implanting as we speak, and we’re working with the FDA to determine a US path for that platform as well.”

The news isn’t unalloyed joy for Medtronic; the Minneapolis group will probably have to work out some kind of royalty deal with Edwards over a patent infringement case – although this should not hit for at least a year – and there is a slim possibility that the US launch of CoreValve will be kyboshed altogether if Edwards is granted an injunction (Edwards valve patent victory could hit Medtronic for $1.6bn, January 16, 2014). This is, however, unlikely.

The importance of the US launch of CoreValve as a catalyst for Medtronic is enormous, the more so since the failure and likely pulling of its renal denervation system, Symplicity, which had been expected to be first to market in the US (Failure of Medtronic’s Symplicity trial exacerbates concerns over renal denervation, January 9, 2014). Ms Robb refused to be drawn on whether the company finds itself more dependent on CoreValve revenues as a result, but the conclusion seems inescapable.

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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