With Renal Denervation for Hypertension looking like a wounded animal at the moment, it’s perhaps surprising to see a company announcing its device has gained regulatory approval. But if the process was underway prior to the bad Symplicity HTN-3 study news, and if the company retains faith in its offering…and if it’s “only” a CE mark, why not?
Background
Johnson and Johnson company, Cordis Corporation has received CE Mark for its RENLANE™ Renal Denervation System for the treatment of patients with resistant hypertension and has completed the first successful cases in Europe. The RENLANE System consists of a unique, helical shaped, irrigated, multi-electrode ablation catheter with a multi-channel radiofrequency (RF) ablation system.
The RENLANE Renal Denervation Catheter features five irrigated electrodes located at the tip of the ablation catheter and is used in conjunction with the RENLANE Multi-Channel RF generator for energy delivery. It is indicated for use in adult patients (> 18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
The first successful cases were performed by Hannes Reuter, M.D., at the University of Cologne Hospital in Germany. The treated patients were diagnosed with resistant hypertension and had systolic blood pressures greater than or equal to 160 mm Hg, despite undergoing traditional drug therapy with three or more anti-hypertensive medications. All procedures were performed successfully and patients were discharged after one day.
So what does this all mean for the therapy? The jolt that was sent through the industry by January’s poor outcome data from the first blinded, sham-controlled study, was enough to derail some companies completely. But Cordis was by then no doubt well on is way to gaining CE Mark approval, which we’re reminded is a measure of safety rather than an endorsement of a device’s clinical efficacy. So it’s unsurprising to see Cordis pushing this approval through, although watching whether renal denervation per se is suffering any drop off will be more telling than one CE mark notification.
Physician comments
“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,” said Hannes Reuter, M.D., University of Cologne, Germany. “The design of the catheter also makes handling the device very easy.”
Company comments
“Chronic hypertension poses a significant health risk to patients and also places a huge burden on global health care systems,” said Celine Martin, Worldwide President, Cordis Corporation. “We are pleased to make our RENLANE Renal Denervation System available to European clinicians in need of solutions for patients who do not respond to traditional drug therapy. And we are looking forward to gaining more experience with this therapy and making it available to more patients in need of treatment around the world.”
Source: Cordis Corporation, Business Wire
published: February 21, 2014 in: Approval/Clearance, Cardio, Johnson & Johnson