St.Jude Medical, Inc. has announced enrollment of the first patient in the EnligHTN III trial, designed to evaluate the safety and performance of its new second-generation EnligHTN™ Renal Denervation System in patients with drug-resistant, uncontrolled hypertension.
St.Jude says enhancements to its EnligHTN Renal Denervation System has the potential to reduce total ablation time from approximately 24 minutes to four minutes. The company says its next-generation system pairs its proven multi-electrode catheter with a new generator that features a high-tech, icon-friendly, touch screen user interface that provides simultaneous ablations using four electrodes.
With its unique non-occlusive basket design, each placement of the ablation catheter using the EnligHTN system administers a predictable treatment pattern while allowing for continuous blood flow to the kidney throughout the procedure. Additionally, the new second-generation EnligHTN generator allows physicians to easily view and record procedure information.
The new study
The EnligHTN III study is an international, non-randomized clinical trial that will enroll up to 50 patients in Australia and New Zealand with drug-resistant hypertension. To qualify for the study, participants must have systolic blood pressure that remains greater than 160 mmHg as measured during office visits, despite the use of three antihypertensive medications concurrently at the maximum tolerated doses, one of which is a diuretic.
This study expands upon the research conducted in the EnligHTN I trial of the first generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe, rapid and sustained drop in blood pressure. In that study, after thirty days, systolic blood pressure was reduced by an average of 28 mmHg, remaining stable with a reduction of 26 mmHg points six months after treatment.
“Lowering hypertension is important as the risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure,” said Prof. Stephen Worthley of St. Andrew’s Hospital in Adelaide, Australia, a principal investigator of the EnligHTN III trial. “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.”
“St. Jude Medical has a long history of advancements in ablation technologies, which allowed us to quickly bring the first-generation EnligHTN system to the European market in early 2012,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “Now, less than one year later, we are pleased to bring this innovative therapy to EnligHTN III, a new clinical study evaluating technology advancements in our next-generation system.”
Source: St.Jude Medical, Inc., Business Wire