St Jude Medical has announced that it has received CE mark approval for the next generation of its EnligHTN renal denervation system. It says the new system has a total ablation time of approximately four minutes, which is an 80% reduction in total ablation time compared with the first-generation system’s time of approximately 24 minutes.
A company press release reports that the new system features an advanced generator that delivers simultaneous ablations via a multi-electrode catheter. It adds that the new system is currently being evaluated in the EnligHTN III study, an international, non-randomised clinical trial that will enrol 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 30 days, systolic blood pressure was reduced by an average of 28mmHg that remained stable with a reduction of 27mmHg points one year after treatment.
“The new EnligHTN system improves the procedure by significantly reducing ablation time and providing optimised ablation monitoring feedback,” said Thomas Lüscher, professor and chairman of Cardiology, at the Cardiovascular Center at the University Hospital in Zurich. “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.”