Cordis Corp, a Johnson & Johnson (NYSE:JNJ) subsidiary, today announced European regulatory approval for its Renlane renal denervation system for treatment of patients with drug-resistant hypertension.
The California device maker has already conducted its initial successful cases in Europe, performed in Germany in patients who were all discharged 1 day after undergoing the procedure, according to a Cordis company statement.
"The Renlane Renal Denervation Catheter features 5 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," according to a press release. "It is indicated for use in adult patients (> 18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure."
Cordis has been pretty quiet about its renal denervation efforts as other industry titans have been fighting for market share amid crumbling public interest. Medtronic (NYSE:MDT) took a $200 million writedown on its renal denervation assets after reporting that the highly anticipated clinical trial of its Symplicity renal denervation device missed its primary efficacy endpoint when compared with a placebo in a blinded study. Full results from the trial are slated to drop at the American College of Cardiology conference in late March.
The technology took a major hit, but the hypertension market remains an alluring one. The World Health Organization estimates that chronic high blood pressure is implicated 9.4 million deaths worldwide every year, accounting for 45% of deaths due to heart disease and 51% of deaths due to stroke. The condition affects 1 in 3 adults worldwide, according to the agency.
Last month Covidien (NYSE:COV) announced that it’s winding down its OneShot program, citing "slower than expected development of the renal denervation market," meaning the end for a U.S. clinical trial of the high blood pressure device. Rival renal denervation players Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ) have both slowed their clinical trials while still defending the technology, saying they expect mechanical differences in the various system may play a role in producing better results.
St. Jude had already stopped short on its Enlightn clinical trial, announcing in December that the company would halt the Enlightn IV clinical trial, just a few months after it began. The study was slated to assess nearly 600 patients, but it was halted over concerns that growing momentum for Medtronic’s Symplicity device would hinder enrollment.
Shortly after the Symplicity trial shocker, 1 of its co-principal investigators said it’s "highly unlikely" that RDN will prove out for hypertension. But Dr. Darrel Francis, who struck a cautionary tone on renal denervation last year, told MassDevice.com that if the Symplicity trial shows even a relatively small benefit, it could make a big difference for patients.
"[T]he world of treatment of hypertension is constructed of small effects, carefully stacked up one on another," Francis told us. "A lasting effect of 5-10 mmHg from a single procedure is a huge benefit to patients, because it is similar to what you get from an additional drug that you have to keep taking daily. Patients find that difficult in real life. That is why they have resistant hypertension – because they are resistant to regularly taking any more (or sometimes any) drugs.
"Renal denervation is for patients who prefer it to actually taking more medications," Francis said.