New Renal Denervation Device Significantly Reduces the Procedure Duration
Published date : 16 May 2013
Article date : 14 May 2013
Mass Device reports that patient enrollment has commenced for a St. Jude Medical sponsored trial to evaluate the safety and performance of a new renal denervation system (in patients with drug-resistant, uncontrolled hypertension) that will significantly reduce the total ablation process from some 24 minutes to around just 4 minutes.
The EnligHTN system delivers radiofrequency energy from an ablation catheter to create lesions along the renal nerves – a network of nerves thought to help control blood pressure. The next-generation system being evaluated in the trial reduces the procedure time thanks to an advanced intuative touch-screen generator which permits 4 simultaneous ablations via electrodes.
They say that this study expands on the research conducted in the EnligHTN I trial of the 1st 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 28 mmHg that remained stable with a reduction of 26 mmHg points six months after treatment.
Althought not approved in the US, the first-generation EnligHTN renal denervation system gained the CE Mark in 2012. As yet, the 2nd-generation EnligHTN system is not approved anywhere in the world.
Source: Ingrid Mezo for Mass Device, 14 May 2013
