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RENLANE™ Renal Denervation System from Cordis Gets CE Mark
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February 24, 2014 -- Even while panels and journals continue to debate the efficacy of renal denervation in treating resistent hypertension, a situation brought to the forefront by Medtronic's announcement in January that its pivotal U.S. renal denervation trial failed to meet its pre-specified endpoint, the Conformité Européenne has bestowed its CE Mark on a brand new system from Cordis Corporation.

Although a number of medical device manufacturers have been developing renal denervation systems, the Cordis RENLANE product has not gotten much publicity. In fact, although the press release below appeared last week on BusinessWire, neither the Cordis nor parent company Johnson & Johnson web sites have any information about the device: specifications, photos, graphics, etc.

In December, St. Jude stopped its EnligHTN IV trial, anticipating recruitment difficulties stemming from an expected early approval of Medtronic's more advanced program, and last month Covidien similarly signaled the end of its own renal denervation effort, due to "slower than expected development of the renal denervation market." Boston Scientific has stated that it would wait to see the presentation of the full SYMPLICITY HTN-3 trial at the ACC meeting at the end of March before discussing further developments in its own program. St. Jude has issued similar statements.

So it is interesting that yet another renal denervation system is now available in the European market.

Darrel Francis, MD
Darrel Francis, MD

Whether or not renal denervation is, as some have suggested, at the end of the road is a matter of some debate. One of renal denervation's biggest critics, Dr. Darrel Francis, gave Angioplasty.Org an extended statement to the contrary when the initial results of the Symplicity trial were announced last month.

He told Angioplasty.Org that he doubted that "the FDA will make the grave error of withholding renal denervation from the American people just on this news that the blood pressure effect did not meet an arbitrary threshold." He added that his team estimates the effect is smaller than 10mmHg but is still "a real benefit for patients."


The press release from Cordis Corporation follows:

Cordis Corporation Receives CE Mark for RENLANE™ Renal Denervation System to Treat Resistant Hypertension

February 21, 2014 -- Fremont, California -- Cordis Corporation announced today that it has received European 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 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.

"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."

Nearly one billion people worldwide live with hypertension, or high blood pressure, and the World Health Organization estimates that it is the cause of one in every eight deaths, making hypertension the third leading cause of death worldwide.[1] Chronic high blood pressure is a serious condition that can lead to increased risk of stroke, kidney disease, heart attack and heart failure. It is estimated that between 15 and 30 percent of treated hypertensive patients are resistant to traditional drug therapy, defined as failure to respond to three or more drugs.[2] Uncontrolled hypertension is a major risk factor for mortality so alternative therapies such as renal denervation for treatment-resistant patients have emerged to help address this patient population. Additionally, the economic burden of the condition is significant. The International Society of Hypertension estimates the annual cost of healthcare expenditure directly related to elevated blood pressure to be almost $500 billion.[3]

"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."[4]

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 RENLANE™ Renal Denervation System is another addition to Cordis' broad and growing portfolio of minimally invasive therapies for patients that suffer from cardiovascular disease worldwide. The company is committed to working with leading clinicians to address the significant and growing burden of cardiovascular disease with innovative endovascular solutions that address the clinical needs of our customers and the patients they treat.

About Renal Denervation
Renal denervation is a minimally invasive, catheter-based treatment for resistant hypertension, or high blood pressure that does not respond to traditional drug therapy (three or more drugs). During the procedure, a thin flexible tube called a catheter is inserted through a small incision in the groin and it is then weaved up to the renal arteries through a blood vessel in the leg. Once the catheter tip is placed inside of a renal artery, radiofrequency (RF) energy is delivered to reduce hyperactivity of the surrounding nerves, which causes the kidneys to produce less of the hormones that are responsible for chronic high blood pressure. Both of the renal arteries are treated during the procedure.

About Cordis Corporation
Cordis Corporation, part of the Johnson & Johnson Family of Companies, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with clinicians to treat millions of patients who suffer from cardiovascular disease worldwide. More information about Cordis Corporation can be found at

[1] The World Health Report 2012. World Health Organization; 2012:58
[2] Pimenta E, Calhoun DA. Resistant hypertension: incidence, prevalence, and prognosis. Circulation. 2012;125:1594-6.
[3] Lawes CM, Vander Hoorn S, Rodgers A; International Society of Hypertension. Global burden of blood-pressure related disease, 2001. Lancet. 2008;371:1513-1518.
[4] The RENLANE™ Renal Denervation System is not available for sale or use in the United States.

Reported by Burt Cohen, February 24, 2014