Renal Denervation System Earns CE Mark

St. Jude Medical Inc. officials announced the CE Mark approval of its next-generation EnligHTN Renal Denervation System, a medical device for treating patients with drug-resistant, uncontrolled hypertension. The system features an advanced generator that delivers simultaneous ablations via a multi-electrode 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 four minutes.

“The new EnligHTN system improves the procedure by significantly reducing ablation time and providing optimized ablation monitoring feedback,” states 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. “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.”

Renal denervation is a catheter-based ablation procedure used to treat patients with drug-resistant hypertension (high blood pressure). The EnligHTN system delivers radiofrequency (RF) energy from an ablation catheter to create lesions (tiny scars) along the renal nerves – a network of nerves in the walls of the renal arteries thought to help control blood pressure. The intentional disruption of the nerve supply has been clinically found to help reduce systolic and diastolic blood pressure. The system catheter has a unique, non-occlusive 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 two times in each renal artery. The advanced generator also has an icon-based touch screen interface that allows physicians to easily view and record procedure information.

“The next generation EnligHTN system offers physicians our proven multi-electrode catheter with a new intuitive, faster generator that quickly and effectively delivers consistent ablations with a significant reduction in procedure time,” says Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “These advancements deliver on our strategy to bring new innovations to a developing market to provide options for patients who currently do not have an adequate treatment for their uncontrolled drug-resistant hypertension.”

Renal denervation represents an important area of research. St. Jude Medical is 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 next-generation 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. This study expands on 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 28mmHg (millimeters of mercury) that remained stable with a reduction of 27mmHg points one year after treatment.

About Hypertension
A normal blood pressure is typically at or below 120 systolic and 80 diastolic, expressed as 120/80mmHg. Hypertension is categorized as a blood pressure reading greater than 140/90mmHg. Lowering hypertension is important as the risk of cardiovascular death doubles with every 20-point increase in systolic blood pressure.

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 (WHO). Known as the “silent killer,” high blood pressure often presents no warning signs or symptoms and many people do not realize they have it. Drug-resistant hypertension is a condition that cannot be controlled through medication. 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.

Recently, the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) 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.

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