No company has a formal, approved renal denervation device on the market in the U.S. to treat drug-resistant hypertension, but they are already on to developing and testing next generation devices.

St. Jude Medical announced Tuesday that it has enrolled the first patient in the EnligHTN III trial, which will enroll up to 50 patients in Australia and New Zealand to evaluate an advancement on its second-generation renal denervation device. Renal denervation involves using a catheter to ablate the renal arteries of patients whose blood pressure is not controlled even by taking multiple medications simultaneously.

The new device combines St. Jude's multi-electrode catheter with a "new generator that features a high-tech, icon-friendly, touch screen user interface that provides simultaneous ablations using four electrodes," the company said in a news release. As a result, ablation time is drastically reduced to four minutes from 24 minutes.

"The ability of the next-generation EnligHTN system to deliver simultaneous ablations and the intuitive touch screen on the generator are advancements that simplified use, markedly reduced procedure times and was well tolerated by our patients," said Prof. Stephen Worthley of St. Andrew's Hospital in Adelaide, Australia, a principal investigator of the EnligHTN III trial, in the news release. 

Meanwhile, Medtronic is also working on a next-generation product of its original, single-electrode Symplicity Renal Denervation System. Like St. Jude's product, it will also have four electrodes. In October, Medtronic announced that it had completed a feasibility trial with nine patients using the multi-electrode renal denervation system.

Both St. Jude and Medtronic have their respective renal denervation devices approved in Europe. Other companies who have acquired renal denervation companies are Covidien, which paid $60 million for Maya Medical and Boston Scientific, which bought Vessix Vascular for upfront payment of $125 million, plus $300 million in additional clinical and sales-based milestones for a total transaction value of $425 million.

-- By Arundhati Parmar, Senior Editor, MD+DI

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