St Jude Medical obtains CE Mark approval for new renal denervation system

29 August 2013 (Last Updated August 29th, 2013 18:30)

US-based medical technology developer St Jude Medical has obtained CE Mark approval for its next-generation EnligHTN renal denervation system, designed for treating patients with drug-resistant, uncontrolled hypertension.

st jude medical

US-based medical technology developer St Jude Medical has obtained CE Mark approval for its next-generation EnligHTN renal denervation system, designed for treating patients with drug-resistant, uncontrolled hypertension.

The next-generation system, which uses the multi-electrode catheter paired with a new generator that provides ablations using four electrodes, will reduce the total ablation time from approximately 24 minutes to four minutes.

The CE-marked EnligHTN renal denervation system is a minimally invasive device featuring a non-occlusive basket design. It delivers radiofrequency energy to create a predictable pattern of four evenly-spaced ablations along the renal sympathetic nerves that help control blood pressure.

Physicians can easily view and record procedure information with the help of an icon based touch screen available with the advanced generator.

"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."

The Cardiovascular Center at the University Hospital in Zurich professor and chairman of cardiology Thomas Lüscher said the new EnligHTN system improves the procedure by significantly reducing ablation time and providing optimized ablation monitoring feedback.

St Jude Medical cardiovascular and ablation technologies division president Frank J Callaghan added: "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."

Including EnligHTNment landmark trial, the company is currently conducting five renal denervation studies.

The next-generation EnligHTN system is currently being evaluated in an international, non-randomized clinical trial, EnligHTN III that expands on EnligHTN I trial research of the first generation EnligHTN system.

The EnligHTN III study is expected to enrol up to 50 patients in Australia and New Zealand.


Image: The next-generation EnligHTN Renal Denervation System. Photo: courtesy of St Jude Medical, Inc.