St. Jude Medical, a US-based medical device company, has enrolled the first patient for the EnligHTN III trial.
During the study, the safety and performance of the second-generation EnligHTN Renal Denervation System in patients with drug-resistant, uncontrolled hypertension is evaluated.
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.
Using the EnligHTN system, each placement of the ablation catheter administers a predictable treatment pattern and allows continuous blood flow to the kidney throughout the procedure.
EnligHTN III trial principal investigator and St. Andrew's Hospital in Adelaide, Australia, professor Stephen Worthley said that lowering hypertension is important as the risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure.
"The ability of the next-generation EnligHTN system to deliver simultaneous ablations and the intuitive touch screen on the generator are advancements that simplified use, markedly reduced procedure times and was well tolerated by our patients," Worthley added.