Medtronic's new version of Symplicity gets a green light in EU and Australia

Medtronic ($MDT) announced Thursday it has approval in the EU and Australia to market its new system for renal denervation to treat uncontrolled hypertension.

The new system's catheter--dubbed Spyral--brings from one to four the number of electrodes in play, reducing ablation times and allowing doctors to turn on and off specific electrodes "to accommodate different anatomies," according to Medtronic.

In August, St. Jude Medical ($STJ) won EU approval for its next-generation renal denervation device, which it said can cut procedure times from 24 minutes down to four.

Results from Medtronic's ongoing U.S. clinical trials are expected in the first half of 2014, after completion in May of a first and only pivotal trial enrolling 535 patients.

Renal denervation targets nerves in the kidneys with radiofrequency pulses that denervate the organs, reducing nerve signals that contribute to high blood pressure. The minimally invasive surgical procedure is used for patients with persistent hypertension--those whose blood pressure remains elevated despite lifestyle changes and a regimen of three or more drugs.

Medtronic acquired Symplicity in 2010 with its $800 million buyout of Ardian, a California startup that had developed the medical technology.

According to the company's news release this morning, its new version of Symplicity--comprising the Symplicity Spyral catheter and Symplicity G3 generator--is designed to "significantly reduce" ablation time and ease delivery. That simplifies the procedure, said Michael Böhm, MD, PhD, Chairman, Department of Internal Medicine, University of Saarland, Homburg/Saar, Germany, in a statement.

Nina Goodheart, vice president and general manager of renal denervation at Medtronic, called the Symplicity Spyral "fast and efficient" and said its features are "designed to meet specific unmet needs."

- read the press release

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