Cordis' Renlane Renal Denervation System Receives CE Mark Approval

February 21, 2014—Cordis Corporation (Bridgewater, NJ) announced that it has received European CE Mark approval for its Renlane renal denervation system for the treatment of patients with resistant hypertension. The Renlane system is composed of a helical-shaped, irrigated, multielectrode ablation catheter with a multichannel radiofrequency (RF) ablation system.

According to Cordis, the Renlane device features five irrigated electrodes located at the tip of the ablation catheter. It is used in conjunction with the Renlane multichannel RF generator for energy delivery. It is indicated for use in adult patients (age > 18 years) with drug-resistant hypertension to denervate the renal arteries to reduce blood pressure. The Renlane renal denervation system is not available for sale or use in the United States.

Cordis said that Hannes Reuter, MD, performed the first cases in Europe with the device at the University of Cologne Hospital in Germany. The treated patients were diagnosed with resistant hypertension and had systolic blood pressures ≥ 160 mm Hg, despite undergoing traditional drug therapy with three or more antihypertensive medications. All procedures were performed successfully, and patients were discharged after 1 day.

In the company’s press release, Dr. Reuter commented, “The novel technological design of the Renlane renal denervation catheter, with its configuration of five electrodes and irrigated technology, allows for shorter procedure duration, sparing of contrasting dye, and likely more protection of the endothelium. The design of the catheter also makes handling the device very easy.”