St. Jude Medical Receives European Approval for New Renal Denervation System That Reduces Total Ablation Time by More Than 80 Percent
Next-generation EnligHTN system for treating hypertension reduces total ablation time from approximately 24 minutes to four minutes
ST. PAUL, Minn.--Aug. 29, 2013-- St. Jude Medical, Inc. today announced the CE Mark approval of its next-generation EnligHTN™ Renal Denervation System 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 percent in comparison to the first generation system, from approximately 24 minutes to four minutes. The EnligHTN system will be on display during the 2013 European Society of Cardiology (ESC) meeting from August 31 to September 3.
The next-generation EnligHTN(TM) Renal Denervation System delivers simultaneous ablations via a multi-electrode catheter, reducing ablation times 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,” said 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.
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 thirty days, systolic blood pressure was reduced by an average of 28 mmHg (millimeters of mercury) that remained stable with a reduction of 27 mmHg points one year after treatment.
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.
To learn more about renal denervation or see a demo of the next-generation EnligHTN Renal Denervation System, ESC attendees can visit St. Jude Medical at booth C310 of Exhibition Hall 1.
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.
For more information, please visit sjm.com.