St. Jude Medical won EU regulatory approval for the latest version of the EnligHTN renal denervation system to control drug-resistant hypertention. The device delivers radiofrequency signals to renal arteries, causing them to scar slightly, that in turn results in reduced activity in the nerves within the vascular walls that are involved in controlling blood pressure.
Thanks to four high energy electrodes at the device tip, the ablation procedure time has been reduced from about twenty four to only four minutes compared to the original EnligHTN. Moreover, the shape of the device prevents occlusion of the renal arteries during the procedure, allowing for a continuous perfusion of the kidneys.
From St. Jude:
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 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.