CE Mark Granted for Next Generation of EnligHTN

Published date : 30 August 2013
Article date : 29 August 2013

A press release from device manufacturer St Jude Medical has announced CE mark approval on the company's next generation EnligHTN Renal Denervation System. The system which is designed for treating patients with drug-resistant, uncontrolled hypertension, cuts total ablation time by over 80% in comparison to the first generation system from approximately 24 minutes to just four minutes. The EnligHTN system will be on display during the 2013 European Society of Cardiology (ESC) meeting from August 31 to September 03 (2013).

“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.  
They say that 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.
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 US.
Source: St Jude Medical
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