St. Jude Medical Gets European Approval For EnligHTN Renal Denervation System

(RTTNews) - Medical device maker St. Jude Medical Inc. (STJ) said Thursday that it received European CE Mark approval for the EnligHTN Renal Denervation System to treat patients with drug-resistant, uncontrolled hypertension. The company noted that the new renal denervation system reduces total ablation time by more than 80 percent.

Renal denervation is a catheter-based ablation procedure used to treat patients with drug-resistant hypertension or high blood pressure.

St. Paul, Minnesota-based St. Jude noted that the EnligHTN renal denervation system features a generator that delivers simultaneous ablations via a multi-electrode catheter, reducing total ablation time from about 24 minutes to 4 minutes.

The EnligHTN system will be on display during the 2013 European Society of Cardiology or ESC meeting from August 31 to September 3.

Thomas Lüscher, professor and chairman of Cardiology, at the Cardiovascular Center at the University Hospital in Zurich and editor in chief of the European Heart Journal said, "The new EnligHTN system improves the procedure by significantly reducing ablation time and providing optimized ablation monitoring feedback. Renal denervation is a relatively simple, minimally-invasive procedure that is emerging as an important new avenue for managing hypertensive patients who do not respond to medications."

The EnligHTN system delivers radiofrequency energy from an ablation catheter to create lesions or tiny scars along the renal nerves - a network of nerves in the walls of the renal arteries that are thought to help control blood pressure. The intentional disruption of the nerve supply has been clinically found to help reduce both systolic and diastolic blood pressure.

A reduction in blood pressure is achieved by simultaneously administering 60 second ablations from all four catheter electrodes, which is typically performed two times in each renal artery. The generator also has an icon-based touch screen interface that enables physicians to easily view and record procedure information.

St. Jude Medical is currently conducting five renal denervation studies, including the EnligHTNment landmark trial. This study is the first large-scale trial that will examine the long-term effects of renal denervation to see if the therapy also reduces the risk of heart attack, stroke, heart failure requiring hospitalization, as well as cardiovascular death in patients with uncontrolled hypertension.

The EnligHTN system is currently being evaluated in the EnligHTN III study, an international, non-randomized clinical trial that will enroll up to 50 patients in Australia and New Zealand.

Hypertension or "high blood pressure" is a common medical condition that can cause life-threatening health problems such as heart disease, stroke or kidney failure that affects one in three adults worldwide, according to the World Health Organization.

There are more than 100 million people worldwide that are treatment resistant where at least three high blood pressure drugs do not work. The annual global health care expenditure directly related to hypertension is estimated at almost 385 billion euros every year.

St. Jude's first-generation EnligHTN Renal Denervation System earned European CE Mark approval in 2012 and was launched in several markets. The EnligHTN systems are not approved for use in the U.S.

In Thursday's regular trading session, STJ is trading at $50.62, up $0.01 or 0.02 percent on a volume of 48,000 shares.