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CE mark received for RENLANE system

Manufacturing Group | February 27, 2014

Cordis Corp. received the European CE mark for system that treats patients suffering from resistant hypertension.

Fremont, Calif. - Cordis Corp. officials announced 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 160mm 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% 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 Corp. “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.

Source: Cordis Corp.

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.

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