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Next-generation renal denervation system receives CE mark

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St. Jude Medical announced that it has received a CE mark approval for its next-generation renal denervation system for patients with uncontrolled hypertension that does not respond to drug treatment.

The system, EnligHTN, has a multi-electrode catheter that can deliver simultaneous ablations, which can reduce total ablation time by approximately 80% compared with the first-generation system, according to information from a company press release.

Through an advanced generator, the system administers 60-second ablations from four catheter electrodes at the same time, typically for two times in each renal artery, according to information from the press release. It also has a touch screen interface enabling viewing and recording of procedure information.

“The new EnligHTN system improves the procedure by significantly reducing ablation time and providing optimized ablation monitoring feedback,” Thomas Lüscher, MD, FRCP, chairman of cardiology at the Cardiovascular Center at the University Hospital, Zurich, Switzerland, said in the press release.

The next-generation system is being evaluated in the EnligHTN III study, a trial including up to 50 patients underway in Australia and New Zealand. In the EnligHTN I trial evaluating the first-generation EnligHTN system, patients receiving the treatment experienced an average reduction in systolic BP of 28 mm Hg after 30 days and 27 mm Hg after 1 year, the company stated in the press release.