J&J Still Betting on Renal Denervation in EuropeJ&J Still Betting on Renal Denervation in Europe

Johnson & Johnson's Cordis Corp. is making strides when it comes to its own renal denervation system for treating high blood pressure--even as questions are raised overall about the treatment. Cordis announced Friday that it has won CE Mark approval for its Renlane system.Hannes Reuter, MD, at the University of Cologne Hospital in Germany, has made the first successful European uses of the Renlane Renal Denervation System, using it to treat patients with high blood pressure who had proved resistant to traditional drug therapies.The treatment involves applying radiofrequency ablation through a catheter to the renal arteries that supply the kidneys with blood, hopefully causing the kidneys to produce less of the hormones that cause chronic high blood pressure.Until recently, medical device industry insiders had high hopes for the treatment. But its effectiveness was called into question last month, when Medtronic's Symplicity renal denervation system failed to effectively treat high blood pressure in a pivotal U.S. clinical trial.It is worth noting that a CE Mark requires evidence of a device's safety, not efficacy, while the U.S. FDA is concerned with both.After last month's Symplicity HTN-3 trial, Medtronic suspended enrollment in renal denervation hypertension trials in three countries where it has been seeking regulatory approval, later announcing that it was reducing valuation of its assets by $236 million. Covidien also beat a retreat, announced that it is exiting its OneShot renal denervation program, which involves technology Covidien acquired through its April 2012 acquisition of Maya Medical.Other medical device companies remain more optimistic about the treatment. Boston Scientific CEO Michael Mahoney has repeated that the medical device giant remains enthusiastic about renal denervation as a treatment for high blood pressure. St. Jude CEO Daniel Starks has expressed similar sentiments.Cordis' Renlane system includes a helical shaped, irrigated, multi-electrode ablation catheter with a multi-channel radiofrequency ablation system."The design of the catheter also makes handling the device very easy," Reuter said in a news release.