St. Jude bags EU approval for next-gen renal denervation

St. Jude's latest EnligHTN system works about 6 times faster than its predecessor, the company said.--Courtesy of St. Jude

As some of the world's largest devicemakers scramble for European market share, St. Jude Medical has secured overseas approval for its second-generation renal denervation system, one it says can slash procedure times while lowering blood pressure.

St. Jude has won a CE mark for the next-gen EnligHTN, giving it a second device to compete in a market analysts say could reach $3 billion a year within the decade.

The new EnligHTN ships with four nerve-deadening electrodes, just like its predecessor, but, instead of firing one by one to drive down hypertension, the latest device delivers ablations all at once. That cuts the total procedure time down from 24 to four minutes, St. Jude said, and the new EnligHTN has so far demonstrated just as effective as the prior model, lowering systolic blood pressure by an average of 27 mmHg after one year.

Getting a faster EnligHTN on the market could help St. Jude grab a larger share of a market currently led by Medtronic ($MDT) and its Symplicity system. Medtronic's device is strapped with a single electrode and has to be moved about the renal artery to work its magic, making for an average procedure time of around 38 minutes, according to the company.

Now, with a speedier tech to sell, St. Jude has a chance to help the more than 100 million drug-resistant hypertension patients around the world, Cardiovascular President Frank Callaghan said.

"The next-generation EnligHTN system offers physicians our proven multi-electrode catheter with a new, intuitive, faster generator that quickly and effectively delivers consistent ablations with a significant reduction in procedure time," Callaghan said.

St. Jude is still in the midst of an international trial of the next-gen device, one of 5 renal denervation studies the devicemaker has going, including the original pilot study, another involving patients with less severe hypertension, one to test how well renal denervation can prevent major cardiovascular events and, finally, a 590-patient study designed to win FDA approval.

Still, Medtronic is almost certainly going to be the first company to profit from renal denervation in the U.S., planning a 2015 launch for Symplicity, and the devicemaker is at work on a second-generation tech of its own, in May touting positive data for the four-electrode Symplicity Spyral.

Covidien ($COV), Boston Scientific ($BSX) and ReCor Medical all have CE marked renal denervation devices.

- read St. Jude's announcement

Special Report: Renal denervation: Medtronic, St. Jude vie for lion's share of billions

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