St. Jude Medical's Next-Generation EnligHTN System Receives CE Mark Approval

August 29, 2013—St. Jude Medical, Inc. (St. Paul, MN) announced the European CE Mark approval of its next-generation EnligHTN renal denervation system for treating patients with drug-resistant, uncontrolled hypertension. The company will introduce the EnligHTN system during the 2013 European Society of Cardiology's ESC Congress 2013 (ESC) meeting from August 31 to September 3 in Amsterdam, The Netherlands. The first-generation EnligHTN system earned CE Mark approval in 2012 and was launched in several markets. The EnligHTN systems are not approved for use in the United States, according to the company.

Thomas Lüscher, MD, who is Professor and Chairman of Cardiology, at the Cardiovascular Center at the University Hospital in Zurich, Switzerland, and Editor-in-Chief of the European Heart Journal, commented in the St. Jude press release, “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.”

According to St. Jude Medical, the new system's advanced generator delivers simultaneous ablations via a multielectrode catheter, reducing total ablation time with the new EnligHTN system by more than 80% in comparison to the first-generation system, from approximately 24 minutes to 4 minutes.

The system catheter has a nonocclusive basket design, helping physicians deliver a predictable treatment pattern while allowing for continuous blood flow to the kidney throughout the procedure. Blood pressure reduction is quickly achieved by simultaneously administering 60-second ablations from all four catheter electrodes, which is typically performed twice in each renal artery. The advanced generator also has an icon-based touch screen interface that allows physicians to view and record procedure information.

St. Jude Medical advised that it is conducting five renal denervation studies. The large-scale EnligHTNment landmark trial 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.

As announced in May 2013, the next-generation EnligHTN system is being evaluated in the EnligHTN III study, an international, nonrandomized clinical trial that will enroll up to 50 patients in Australia and New Zealand. This study expands on the EnligHTN I trial research of the first-generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe, rapid, and sustained drop in blood pressure. After 30 days, systolic blood pressure was reduced by an average of 28 mm Hg, which remained stable with a reduction of 27 mm Hg points 1 year after treatment.

The company noted that in June 2013, the European societies issued guidelines recommending the use of catheter-based renal denervation for the treatment of high blood pressure in patients with difficult-to-treat, drug-resistant hypertension.